Zinc Oxide 20% by SOLA Pharmaceuticals ZINC OXIDE 20% ointment

Zinc Oxide 20% by

Drug Labeling and Warnings

Zinc Oxide 20% by is a Otc medication manufactured, distributed, or labeled by SOLA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 20%

Purpose

Skin protectant

Uses

Skin Protectant

• Helps treat and prevent diaper rash
• Dries the ozzing and weeping of poison: Ivy Oak Sumac

Warnings

For external use only

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
• For poison ivy, oak, and sumac: Apply as needed

Other Information

• Store at room temperature
• Avoid excessive heat and humidity

Inactive ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide 20% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-103-30	1 in 1 CARTON	04/22/2021
1		28.4 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 final	part347	04/22/2021

Labeler - SOLA Pharmaceuticals (080121345)