DermaRite Industries
7777 West Side Avenue
North Bergen, NJ 07047

Dear Valued Customers and Partners,

We’d like to share an important update regarding our voluntary product recall. Our team has been working diligently to assist impacted customers as a result of this voluntary product recall, and we are actively implementing measures to ensure resolution.

We recognize the impact this situation may have caused and sincerely regret any inconvenience. Restoring full product availability is our highest priority.

Importantly, we want to confirm that our wound care and nutritional products are not part of this voluntary product recall and remain available for your continued use.

Our actions reflect our dedication to acting quickly, transparently, and responsibly, so that we can maintain the highest standards of care.

We will continue to provide further updates as additional information becomes available.

We greatly appreciate your cooperation, patience, and trust as we work through this process together.

Respectfully,

The DermaRite Team

FOR IMMEDIATE RELEASE
DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the table below. Please see DermaRite.com for the original recall notice.

Risk Statement: Burkholderia cepacia complex in these products may result in serious and life-threatening infections if the products are used by immunosuppressed individuals or by people attending to immunosuppressed individuals. For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis.

The products included in this expanded voluntary recall include:

3-N-1 is a thick foaming, rinse-free, body wash, shampoo, and perineal cleanser. Enriched with Aloe Vera, it soothes and moisturizes fragile skin as it cleans.

4-N-1 is a no rinse wash cream intended to temporarily protect and help relieve chafed or cracked skin

Clean-N-Free is a mild, rinse-free, body wash, shampoo, and perineal cleanser that cleans and refreshes without water. Perfect for bed-bound residents and patients.

DermaCerin is a skin protectant moisturizing cream indicated to temporarily protect and help relieve dry, chapped, or cracked skin. It also helps protect skin from the drying effects of wind and cold weather.

DemaDaily is a moisturizing lotion that soothes dry, sensitive skin.

DermaFungal is an OTC antifungal cream intended for the treatment and prevention of most athlete’s foot, jock itch, and ringworm. It relieves itching, scaling, cracking, and discomfort associated with these conditions.

DermaKleen is an OTC healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.

DemaKlenz is a mild, non-irritating wound cleanser. Gentle on sensitive wounds. Effectively removes debris and dead tissue. No rinsing necessary. Reduces Odor

DermaMed is an OTC skin protectant intended to dry the oozing and weeping of poison ivy, oak, or sumac, or other skin irritations.

DermaRain is an extra mild bodywash and shampoo that is pH balanced and dye free. Suitable for all skin types.

DermaSarra is an OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, or sunburn.

DermaSyn is a hydrogel wound dressing that provides and helps maintain a moist wound environment, facilitating autolytic debridement.

DermaVantage moisturizing lotion soothes and moisturizes dry, sensitive skin.

DermaVera is a full body cleanser suitable for skin and hair. Moisturizes with shea butter.

Gel Rite is an OTC instant gel hand sanitizer with vitamin E used to decrease bacteria on the skin. It is recommended for repeated use.

Hand E Foam is an OTC foaming hand sanitizer with vitamin E used for handwashing to decrease bacteria on the skin. It is recommended for repeated use.

KleenFoam is an OTC antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.

Lantiseptic is an OTC skin protectant indicated to temporarily protect minor cuts, scrapes and burns. It helps prevent and temporarily protect chapped or cracked skin.

LubriSilk is a lotion that soothes, lubricates, and softens rough, dry skin. Use on hands, face, legs, elbows and heels for healthy, moisturized skin.

PeriFresh is a mild cleanser spray designed for incontinence use. Perifresh’s non-drying formula nourishes your skin with aloe vera, leaving your skin clean and healthy. More convenient than conventional soap and water, it cleans and deodorizes with a light fruit fragrance.

PeriGiene is an OTC antiseptic cleanser indicated for use in the perineal area.

PeriGuard is an OTC skin protectant indicated to help relieve and prevent rashes and irritation due to wetness from incontinence. It also protects chafed skin due to irritation and helps seal out wetness.

Renew Hair and Body Wash is formulated to nourish and clean from head to toe. The rich, creamy lather soothes and softens skin and hair with a blend of beneficial vitamins and shea butter. Fresh tropical coconut scent.

Renew Dimethicone is an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritations associated with diaper rash, and helps seal out wetness.

Renew Full Body Wash & Shampoo is a mildly formulated bodywash & shampoo, suitable for hands, body, hair, and perineal care. This non-drying formula nourishes your skin with aloe vera, leaving your skin clean and healthy. Light fruit fragrance.

Renew Periprotect is an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritation associated with diaper rash, and helps seal out wetness.

Renew Skin Repair is an OTC Skin cream indicated to temporarily protect and help relieve chapped or cracked skin. It is beneficial for face, hands, body and legs.

San-E-Foam is a foaming hand sanitizer with vitamin E use for handwashing to decrease bacteria on the skin. Is recommended for repeated use.

TotalBath is a head-to-toe bodywash and shampoo. Enriched with vitamin E, it moisturizes as it cleans for soft, healthy skin and hair.

TotalFoam is a mildly formulated bodywash & shampoo, suitable for hands, body, hair, and perineal care. TotalFoam’s non-drying formula nourishes your skin with aloe vera, leaving your skin clean and healthy. Light fruit fragrance.

UltraSure is an OTC anti-perspirant & deodorant indicated to reduce underarm wetness.

WhirlBath is a head-to-toe bodywash and shampoo, specially formulated with mild cleansers and conditioners for whirlpool and tub use.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

Consumers with questions regarding this recall can call Sedgwick at 888-943-5190 Monday through Friday, 8:00 am – 5:00 pm EST or email dermarite5186@sedgwick.com

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product or have questions about whether the product was used in their health care facility.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Recalled Product Information:

Labels of affected products can be viewed here.

FOR IMMEDIATE RELEASE
DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

Risk Statement: Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis. To date, DermaRite has not received any reports of adverse events related to this recall.

DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.

DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to: dry skin, insect bites, detergents, sunburn.

KleenFoam is an OTC Antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.

PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

Recalled Product Information:

DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

Consumers with questions regarding this recall can call Mary Goldberg at 973-569-9000 x104 Monday through Friday, 9:00 am – 5:00 pm EST or email voluntary.action@dermarite.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Labels of affected products can be viewed here.