ZINC OXIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

ZINC OXIDE- ZINC OXIDE CREAM
WESTMINSTER PHARMACEUTICALS, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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ZINC OXIDE
_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, caprylyl glycol, ceteareth- 20, cetyl
alcohol, chlorphenesin,
glycerine, mineral oil, phenoxyethanol, purified water, stearyl
alcohol, tocopheryl acetate
(vitamin E), white petrolatum
QUESTIONS?
Call 1-844-221-7294.
PRINCIPAL DISPLAY PANEL - 113 GRAMS 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
ZINC OXIDE
zinc oxide cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69367-188
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
22 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYC