ZINC OXIDE- zinc oxide ointment
BRANDS INTERNATIONAL

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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GenMed ZINC OXIDE Ointment USP with Blue Dye

Active ingredient

Zinc Oxide (20% w/w)

Purpose

Skin Protectant

Purpose

helps treat and prevent diaper rash
dries the oozing and weeping of poison ivy, poison oak, poison sumac

Warnings

For external use only

When using this product

do not get into eyes
do not use over large areas of the body

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Directions

for diaper rash
change wet and soiled diapers promptly
cleanse the diaper area and allow to dry
apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
for poison ivy, oak, sumac
apply ointment liberally as often as needed

Other information

store at 59°-86° F (15°-30°C)
avoid excessive heat

Inactive ingredients

mineral oil, petrolatum

PACKAGE LABEL

zinc

ZINC OXIDE
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-333-45	454 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/15/2023

Labeler - BRANDS INTERNATIONAL (243748238)