ZINC OXIDE- zinc oxide ointment cream

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Gentell, Inc,., Gentell,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only. Avoid contact with eyes.

Stop use & 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.

Uses

Helps treat & prevent diaper rash.

Protects chafed skin assoicated with diaper rash & helps

protect from wetness. Effective for treating poison ivy,

poison oak & sumac.

Inactive Ingredients

Light Mineral Oil & White Petrolatum

Active Ingredients (In each gram)

Zinc Oxide 20% Skin Protectant

Directions

Gently cleanse affected area and allow to dry before application.

Apply ointment liberally & as often as necessary.

For diaper rash, chage wet and soiled diapers promptly.

Use with each diaper change, especially when exposure to wet

diapers may be prolonged.

Other Information

Lot Number & Expiration Date; see bottom of container.

Store at controlled room temperature (59ºF - 86ºF).

KEEP OUT OF REACH OF CHILDREN

For external use only. Avoid contact with eyes.

Stop use & 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.

PURPOSE

Helps, treats and prevents diaper rash. Protects chafed skin associaed with diaper rash & helps protect from wetness.

Effective in treating poison ivy, poison oak and sumac.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61554-234(NDC: 71395-715)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.2 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61554-234-01	28.3 kg in 1 TUBE; Type 0: Not a Combination Product	03/24/2017
2	NDC: 61554-234-00	454 kg in 1 JAR; Type 0: Not a Combination Product	03/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/03/2014

Labeler - Gentell, Inc,. (170967876)

Establishment
Name	Address	ID/FEI	Business Operations
Gentell,Inc.		170967876	repack(61554-234)