ZINC OXIDE- skin protectant ointment

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. 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

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 right away.

Directions

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

Other Information

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
• Store at room temperature.
  • Preserve in well-closed container.
  • See crimp of tube or carton for Lot number and Expiry Date.

Inactive Ingredients

Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum.

Questions?

Contact 1-800-707-4621

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai- 400710.

For BluePoint Laboratories

Tube and carton 30 g

Tube and carton 60 g

Jar Label 454 g

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-532
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-532-45	1 in 1 CARTON	03/24/2022
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-532-46	1 in 1 CARTON	03/24/2022
2		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	03/24/2022

ZINC OXIDE 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-533
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-533-50	454 g in 1 JAR; Type 0: Not a Combination Product	03/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/24/2022

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-532, 68001-533)