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Drug Facts
Hydrocortisone Cream
FDA Label NDC 0924-1133
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 Hydrocortisone (NDC 0924-1133). 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 other, active ingredient, purpose, uses:, warnings, otc - do not use, otc - stop use, 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
Active Ingredient
Hydrocortisone 1.0%
Purpose
Anti-itch
Uses:
For temporary relief of itching associated with minor skin irritations and rashes.
Other uses of product should be only under the advice and supervision of a doctor
Warnings
For external use only
Otc - Do Not Use
- Do not use
- in eyes
- for diaper rash
Otc - Stop Use
Stop use and ask a doctor if
▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days
▪ you begin using other hydrocortisone products
Keep Out Of Reach Of Children.
If swallowed, contact a Poison Control Center right away.
Directions:
Adults and children over 2 years of age
- apply to affected area not more than 3 to 4 times daily
- children under 2, consult a doctor
Inactive Ingredients
emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
Questions
1.800.835.2263
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