ZINC OXIDE 20%- zinc oxide 20% ointment 
SOLA Pharmaceuticals

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 20% Ointment

Active Ingredient

Zinc Oxide 20%

Purpose

Skin protectant

Uses

Skin Protectant

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help

Directions

Other Information

Inactive ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810


Store at room temperature. Avoid excessive heat and humidity.

Zinc Oxide 20% Ointment

NDC 70512-103-30


Qty: 28.4g

Zinc Carton

ZINC OXIDE 20% 
zinc oxide 20% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70512-103-301 in 1 CARTON04/22/2021
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/22/2021
Labeler - SOLA Pharmaceuticals (080121345)

Revised: 7/2022
Document Id: e314cc52-3f75-9a9c-e053-2a95a90a3f4a
Set id: c091d3ed-f317-9193-e053-2a95a90a4917
Version: 3
Effective Time: 20220705
 
SOLA Pharmaceuticals