Active Ingredient
Hydrocortisone 1%
First Aid Only Anti-itch Cream
FDA Label NDC 0924-5638
9 label sections · Submitted to the FDA by Acme United Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product First Aid Only Anti-itch Cream (NDC 0924-5638). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Uses
- temporarily relieves itching associated with minor skin irritations and rashes
- other uses should be only under the advice and supervision of a doctor
Warnings
For external use only.
Avoid contact with the eyes.
Stop use and consult a doctorif condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days; do not begin use of any other hydrocortisone product.
Do not use for the treatment of diaper rash. Consult a doctor.
Keep out of reach of children. If swallowed get medical help or contact poison control right away.
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: Do not use, consult a doctor
Other Information
store at room temperature 68-77°F (20-25°C)
Inactive Ingredients
ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, water, white petrolatum
Keep Out Of Reach Of Children.
Keep out of reach of children. If swallowed get medical help or contact poison control right away.
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