ZINC OXIDE 20%- zinc oxide ointment

Zinc Oxide 20% by

Drug Labeling and Warnings

Zinc Oxide 20% by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient 

Zinc Oxide 20% w/w

Purpose

Skin Protectant

Uses

Dries the oozing and weeping of poison: Ivy Oak Sumac

Warnings

For External Use Only
When using this product
Do not get into eyes
Do not use over large areas of the body
Stop use and ask a doctor if
The condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days
If you are allergic to any of these ingredients
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

KEEP OUT OF REACH OF CHILDREN

Directions

For poison ivy, oak, and sumac: apply as needed.

Other information

Store at room temperature between 15°-30°C (59°-86°F)
Avoid excessive heat

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Light Mineral Oil, White Soft Paraffin (Petrolatum)

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Product label

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-082-06	1 in 1 BOX	02/01/2025
1		60 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 Drug	M016	02/01/2025

Labeler - Pharmaceutica North America, Inc. (962739699)