DERMOGEN- zinc oxide cream

DERMOGEN by

Drug Labeling and Warnings

DERMOGEN by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 15.25%

Purpose

Skin protectant

Uses

  helps treat and prevent diaper rash 

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

Warning

​ For external use only.

When using this product do not get into eyes

Stop and ask a doctor if condition worsens symptoms lasts 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, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Other information

Store at controlled room temperature 15°-30°C (59°-86°F) Do not use if seal is broken

SPL UNCLASSIFIED SECTION

For the Treatment & Prevention of Diaper Rash

Contains the same active ingredient as Dermocrem®

Manufactured in the USA for Kramer Novis,
San Juan, PR 00917. T: (787) 767-2072.
www.kramernovis.com

Dermocrem® is a registered trademark of Forest Tosara Ltd. This product is not manufactured, distributed or marketed by Forest Tosara Ltd.

Packaging

INGREDIENTS AND APPEARANCE

DERMOGEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-680
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-680-04	113.4 g in 1 JAR; Type 0: Not a Combination Product	04/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/04/2016

Labeler - KRAMER NOVIS (090158395)