Delsam Pharma's Diaperene™ Maximum 40% Zinc Oxide Diaper Rash Cream

DIAPERENE MAXIMUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

DIAPERENE MAXIMUM- zinc oxide cream 
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 Diaperene™ Maximum 40% Zinc Oxide Diaper Rash Cream

DRUG FACTS

ACTIVE INGREDIENT

Zinc Oxide 40%

PURPOSE

Skin Protectant

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only.

When using this product

Do not get into eyes

Stop use and ask a doctor if

Condition worsens

Symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Change wet and soiled diapers promptly Cleanse the diaper area Allow to dry Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

Store at 20°C to 25°C (68°F to 77°F) May stain clothing

Inactive ingredients

White soft paraffin, Glycerine, Purified talc, Light liquid paraffin, Purified water

Questions or Comments

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

*Compare to the active ingredient in Desitin®Maximun Strength

Protects against diaper rash from the first use

Free from Parabens, Phthalates, Dyes and Fragrance Hypoallergenic. Pediatrician & Dermatologist tested

| Provides overnight protection | Instantly forms a protective barrier | Healing you can see, relief your baby can feel |

Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543

Packaging

DIAPERENE MAXIMUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-124-16	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	part347	04/01/2021	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: d2a4261a-d34c-47c3-be9e-b1c7ac386af1

34390-5

Set id: 4d4d7e8f-189d-4a46-8065-db13c1924a40

Version: 2

Effective Time: 20230315