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NDC 69842-0065-34 CVS Zinc Oxide 200 mg/g Details

CVS Zinc Oxide 200 mg/g

CVS Zinc Oxide 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	69842-0065
Product ID	69842-065_8381d820-c27a-48ef-9d01-e9540c49362e
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 Zinc Oxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	200
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 69842-0065-34 (69842006534)

Pricing Information	N/A
NDC Package Code	69842-065-34
Billing NDC	69842006534
Package	1 TUBE in 1 CARTON (69842-065-34) / 28 g in 1 TUBE
Marketing Start Date	2014-05-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d67533b1-ae3f-4c9a-a6c9-a742290c90e9 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

apply liberally as often as necessary

For diaper rash:

change wet or soiled diapers promptly
cleanse the diaper area and allow to dry
apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Store at room temperature 20° - 25°C (68° - 77°F).

Zinc Oxide Tube 1oz

CVS Pharmacy

ZINC OXIDE

Skin Protectant Ointment

ZINC OXIDE 20% NET WT 1 oz (28g)

CVS Zinc Oxide 1 oz Carton

CVS Pharmacy

Zinc Oxide

Skin Protectant Ointment

Zinc Oxide 20% NET WT 1 oz (28g)

INGREDIENTS AND APPEARANCE

CVS ZINC OXIDE

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-065
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-065-34	1 in 1 CARTON	05/30/2014
1		28 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	05/30/2014

Labeler - CVS Health (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	manufacture(69842-065)

Revised: 9/2016

Document Id: 8381d820-c27a-48ef-9d01-e9540c49362e

Set id: d67533b1-ae3f-4c9a-a6c9-a742290c90e9

Version: 1

Effective Time: 20160901