Delsam Pharma's  Diaperene™ Maximum

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

DRUG FACTS

ACTIVE INGREDIENT

Zinc Oxide 40%

PURPOSE

Skin Protectant

Uses

Helps treat and prevent diaper rash

Protect 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 or 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

Light Liquid Paraffin, White Petroleum Jelly, Hard Paraffin Wax, Microcrystalline Wax, Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, Bees Wax, Sorbitol, Phenoxyethanol, Shea Butter, Dimethicone-3031, Magnesium Sulphate & Potassium Hydroxide

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® Maximum Strength

Protects against diaper rash from the first use

Diaper Rash Cream

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: 72570-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 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)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
SORBITOL (UNII: 506T60A25R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-133-16	454 g in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2021	09/27/2021
2	NDC: 72570-133-09	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	part347	07/01/2021	09/27/2021

Labeler - Delsam Pharma Llc (081369679)

Revised: 9/2021

Document Id: 8aa91a30-82af-49a8-a8c7-23e9a36e2583

34390-5

Set id: 02afd3f4-bbc7-4f13-8454-40bfd9d4c9dd

Version: 3

Effective Time: 20210927