Drug Facts

Active ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect skin from wetness.

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask a doctor if

conditions worsen
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 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 20-30°C (68-86 °F)

Inactive ingredients

aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum

Questions?

Call 1-844-221-7294.

PRINCIPAL DISPLAY PANEL - 113 gram Tube Label

Soothing Aloe &
Vitamin E

NDC 69367-188-04

Zinc Oxide 22%

Daily Moisturizing
Diaper Rash Cream

Premium Skin Protectant

Helps Heal, Soothe & Prevent Diaper Rash
Protects Chafed Skin
Gentle on Sensitive Skin

NET WT: 4 oz (113 grams)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 113 gram Tube Label

ZINC OXIDE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69367-188
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69367-188-04	113 g in 1 TUBE; Type 0: Not a Combination Product	07/29/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M016	07/29/2021

Labeler - Westminster Pharmaceuticals, LLC (079516651)