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NDC 69842-0702-10 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	69842-0702
Product ID	69842-702_204ed9e4-75aa-4484-b447-fa87287035bf
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 69842-0702-10 (69842070210)

Pricing Information	N/A
NDC Package Code	69842-702-10
Billing NDC	69842070210
Package	24 PACKET in 1 CARTON (69842-702-10) / 3 g in 1 PACKET
Marketing Start Date	2018-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7e53f282-dd04-4c6d-8ccc-55d2d763b8c3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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

condition worsens
symptoms last 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 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 15° - 30°C (59° - 86°F)

Inactive ingredients

Petrolatum, Glycerin, Cod Liver Oil, Sorbitan Sesquioleate, Lanolin, Beeswax, Talc, Tocopheryl Acetate, Fragrance

Principal Display Panel - Carton Label

Diaper Rash

Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben & phthalate free

Helps Treat and

Prevent Diaper Rash

24 Packettes

NET WT. 0.10 oz(3G) Each

Total -2.4 oz (68G)

Principal Display Panel - Packet Label

CVS Health

Diaper Rash

Ointment

40% Zinc Oxide Skin Protectant

Promotes Healing
Relieves chafing
Paraben and phthalate free

NET WT 0.10 oz(3G)

INGREDIENTS AND APPEARANCE

CVS HEALTH DIAPER RASH

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-702
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
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-702-10	24 in 1 CARTON	06/30/2018
1		3 g in 1 PACKET; 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	06/30/2018

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals, LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals, LLC		151177797	MANUFACTURE(69842-702)

Revised: 8/2018

Document Id: 204ed9e4-75aa-4484-b447-fa87287035bf

Set id: 7e53f282-dd04-4c6d-8ccc-55d2d763b8c3

Version: 1

Effective Time: 20180803