Active Ingredient
Hydrocortisone 1%
First Aid Only Hydrocortisone 1% Anti-itch Cream
FDA Label NDC 0924-5633
Full FDA labeling including 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 Hydrocortisone 1% Anti-itch (NDC 0924-5633). 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, do not use, when using this product, stop use and ask a doctor if, otc - 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
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.
Do Not Use
for a diaper rash. Consult a doctor.
When Using This Product
- Avoid contact with the eyes
- Do not begin use of any other Hydrocortisone product unless you have asked a doctor
Stop Use And Ask A Doctor If
▪ condition worsens or symptoms persist for more than 7 days
▪ symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed get medical help or contact poison control (800-222-1222) 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 15° to 30°C (59° to 86°F)
Inactive Ingredients
ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin
Other
Questions 1.800.835.2263
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