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 GERITREX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
• dries the oozing and weeping of, poison ivy, poison oak and poison sumac

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

apply liberally as often as necessary

For diaper rash:

• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

Store at controlled room temperature 20°-25°C (68°-77°F).

Inactive ingredients

mineral oil, petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-040-28	28 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2018
2	NDC: 54162-040-56	56 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2018
3	NDC: 54162-040-16	454 g in 1 JAR; Type 0: Not a Combination Product	09/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/17/2018

Labeler - GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX LLC		112796248	manufacture(54162-040)