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.
Zinc Oxide
FDA Label NDC 61554-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell, Inc,. for the product Zinc Oxide (NDC 61554-234). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, uses, inactive ingredients, active ingredients (in each gram), directions, other information, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (59°F - 86°F).
Otc - 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.
Otc - 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.
Package Label.Principal Display Panel
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