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NDC 52083-0680-04 DERMOGEN 15.25 g/100g Details

DERMOGEN 15.25 g/100g

DERMOGEN is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. The primary component is ZINC OXIDE.

Product Information

NDC	52083-0680
Product ID	52083-680_260104be-70ab-461e-b8e4-11371407fbbc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DERMOGEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	15.25
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	KRAMER NOVIS
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52083-0680-04 (52083068004)

Pricing Information	N/A
NDC Package Code	52083-680-04
Billing NDC	52083068004
Package	113.4 g in 1 JAR (52083-680-04)
Marketing Start Date	2016-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 38e02d1c-c143-4da6-ad32-a3ce2861aac5 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - KRAMER NOVIS (090158395)

Revised: 11/2018

Document Id: 260104be-70ab-461e-b8e4-11371407fbbc

Set id: 38e02d1c-c143-4da6-ad32-a3ce2861aac5

Version: 2

Effective Time: 20181122