Zinc Oxide 20% by Pharmaceutica North America, Inc.

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]

ZINC OXIDE 20%- zinc oxide ointment 
Pharmaceutica North America, Inc.

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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.

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)

Questions or comments? (888)788-6472

Product label

image descriptionimage description

ZINC OXIDE 20% 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 45861-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 45861-082-061 in 1 BOX02/01/202512/31/2025
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01602/01/202512/31/2025
Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 12/2025
Document Id: 471be45c-b7a7-ec9a-e063-6294a90ae569
Set id: 093302ce-ecf8-4df8-b671-a9ded4ab2c21
Version: 2
Effective Time: 20251229