Delsam Pharma's DiapereneTM 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.

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Delsam Pharma's DiapereneTM 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

Lanolin, White soft paraffin, Light liquid paraffin, Calamine, Glycerin, Propylene glycol

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

Helps and Protects Heal Skin Irritations From :

♦ Diaper Rash
♦ Minor Cuts & Scrapes
♦ Wound Drainage
♦ Burns/ Irradiated Skin
♦ Bedsores
♦ Incontinence of Urine or Diarrhea
♦ Feeding Tube Site Leakage

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: 72570-125
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	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-125-16	454 g in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2021	03/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2021	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: b06c3c12-c134-487c-aabe-601c4a2af7c4

34390-5

Set id: 895d81b9-90a3-4a56-838a-68c3d6e4baa7

Version: 2

Effective Time: 20230315