Dermogen cream

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 productdo not get into eyes

Stop and ask a doctor ifcondition worsens symptoms lasts more than 7 days or clear up and occur again within a few days

Otc - keep out of reach of children section

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 15-30C (59-86F) 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.

Ingredients and appearance - Product information

Dermogen cream- Zinc oxide

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc cation - UNII: 13S1S8SF37 ) 15.25 gin 100 g

Inactive Ingredients

Ingredient Name Code
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

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA

Labeler - KRAMER NOVIS( 090158395)

Packaging