CVS HEALTH DIAPER RASH- zinc oxide cream

CVS Health Diaper Rash by

Drug Labeling and Warnings

CVS Health Diaper Rash by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide (13%)

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

• do not get into 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
• allow to dry
• apply cream 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 20° to 25°C (68° to 77°F)
• protect from freezing
• may stain clothing

Inactive ingredients

Water, Mineral Oil (Paraffinium Liquidum), Petrolatum, Beeswax, Sorbitan Sesquioleate, Glycerin, Microcrystalline Wax, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Magnesium Sulfate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Potassium Hydroxide.

Principal Display Panel – Box Label

CVS

Health®

Compare to the active
ingredient in Desitin® Daily
Defense Diaper Rash Cream*

Cream

Diaper
Rash
Cream

ZINC OXIDE 13%

Skin protectant

Daily use for
diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

Principal Display Panel – Tube Label

CVS

Health®

Cream

Diaper
Rash
Cream

ZINC OXIDE 13%

Skin protectant

Daily use for
diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

CVS HEALTH DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-449
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Cation	14.7 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-449-04	1 in 1 BOX	04/01/2020
1		113 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	04/01/2020

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-449)