Search by Drug Name or NDC

NDC 69842-0058-20 CVS Health Diaper Rash 400 mg/g Details

CVS Health Diaper Rash 400 mg/g

CVS Health Diaper Rash is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is ZINC OXIDE.

Product Information

NDC	69842-0058
Product ID	69842-058_dba58892-fd3f-44a7-ade6-17333844b05f
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	CVS Health Diaper Rash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0058-20 (69842005820)

Pricing Information	N/A
NDC Package Code	69842-058-20
Billing NDC	69842005820
Package	1 TUBE in 1 CARTON (69842-058-20) / 113.4 g in 1 TUBE
Marketing Start Date	2010-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 12f786a0-0960-4b98-9f0b-dcf3725a9866 Details

Drug Fact

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

avoid contact with eyes

Stop use and ask a doctor if

if condition worsens or does not improve in 7 days. This may be a sign of a seriuos condition.

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, and allow to dry
apply ointment 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 room temperature 20° - 25°C (68° - 77°F)

Inactive ingredients

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Tube /Carton Label

CVS Health Compare to the Active Ingredients in Desitin

Maximuim Strength

Diaper Rash Ointment

ZINC OXIDE 40%

Skin protectant

NET WT 4 oz ( 113g)

INGREDIENTS AND APPEARANCE

CVS HEALTH DIAPER RASH

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-058
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-058-20	1 in 1 CARTON	03/31/2010
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/31/2010

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals, LLC		151177797	MANUFACTURE(69842-058)

Revised: 3/2017

Document Id: dba58892-fd3f-44a7-ade6-17333844b05f

Set id: 12f786a0-0960-4b98-9f0b-dcf3725a9866

Version: 1

Effective Time: 20170320