Delsam Pharma's Diaperene™ Adult

Diaperene Adult by

Drug Labeling and Warnings

Diaperene Adult by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIAPERENE ADULT- menthol, zinc oxide ointment 
Delsam Pharma Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Delsam Pharma's Diaperene™ Adult

DRUG FACTS

ACTIVE INGREDIENT

Menthol 0.44%

Zinc Oxide 20.6%.

PURPOSE

External Analgesic / Anti-itch

Skin Protectant, Anorectal Astringent

Uses

Protects and Helps Heal Skin Irritations From Incontinence of Urine or Diarrhea Feeding Tube Site Leakage Diaper Rash Wound Drainage Minor Cuts & Scrapes Bedsores Burns/ Irradiated Skin Temporarily Relieves Discomfort & Itching

Warnings

For external use only. Not for deep or puncture wounds. Avoid contact with eyes. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor.

When using this product

Certain persons can develop allergic reactions to ingredients in this product.  Do not put this product into the rectum by using fingers or any mechanical device or applicator.  Do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor if

Bleeding occurs  Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

Keep out of reach of children

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Diaperene Adult Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other information

Store between: 15-30°C (59-86°F)

Inactive ingredients

Light Liquid Paraffin, White Petroleum Jelly, Hard Paraffin Wax, Microcrystalline Wax, Calamine, Lanolin, Glycerin, Cetostearyl alcohol, Cetyl Alcohol & Thymol.

Questions or Comments

1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to delasampharma@yahoo.com

* Compare to the active ingredient in Calmoseptine® Ointment

A Multipurpose Moisture Barrier Ointment

LONG - LASTING PROTECTION

Temporarily protects irritated areas

Temporary relief of pain or burning and skin irritations

Distributed by:

DELSAM PHARMA LLC

MAMARONECK NY 10543

Packaging

DIAPERENE ADULT 
menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	206 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LANOLIN (UNII: 7EV65EAW6H)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-134-16	454 g in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2021	09/27/2021
2	NDC: 72570-134-09	1 in 1 CARTON	09/06/2021	09/27/2021
2		256 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/01/2021	09/27/2021

Labeler - Delsam Pharma Llc (081369679)

Revised: 9/2021

Document Id: 876514f9-92b6-4138-86b6-34cb91e2ccd7

34390-5

Set id: 61bbd3e0-3895-4b4c-9e5e-db41f3a8bf50

Version: 3

Effective Time: 20210927