CVS HEALTH DIAPER RASH- zinc oxide ointment

CVS Health Diaper Rash by

Drug Labeling and Warnings

CVS Health Diaper Rash by is a Otc medication manufactured, distributed, or labeled by CVS Health, Sheffield Pharmaceuticals LLC, Sheffield Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/31/2010

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

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