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Zinc Oxide by Gentell, Inc,.

Medically reviewed on Mar 22, 2017

Dosage form: cream
Ingredients: ZINC OXIDE 0.2kg in 1kg
Labeler: Gentell, Inc,.
NDC Code: 61554-234

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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).

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.

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.

ZINC OXIDE 
zinc oxide ointment cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-234(NDC:71395-715)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION0.2 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:61554-234-0128.3 kg in 1 TUBE
2NDC:61554-234-00454 kg in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/03/2014
Labeler - Gentell, Inc,. (170967876)
Establishment
NameAddressID/FEIOperations
Gentell,Inc.170967876repack(61554-234)

 
Gentell, Inc,.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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