Active Ingredient
Hydrocortisone acetate (equivalent to Hydrocortisone 1%)
Hydrocortisone
FDA Label NDC 52124-0007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid for the product Hydrocortisone (NDC 52124-0007). 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:, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Maximum strength Anti-itch
Uses
For temporary relief of itching associated with minor skin irritations and rashes due to eczema, seborrheic dermatitis, insect bites, poison ivy, poison oak, poison sumac, sores, detergents, cosmetic and jewelry. Other uses of this product should be only under supervision of a physician.
Warnings
For external use only.
Do Not Use:
In eyes. On children under 2 years of age, unless under advice and supervision of a doctor.
If condition persists for more than 7 days.
Keep Out Of Reach Of Children
If ingested, get medical help or contact a Poison Control Center immediately.
Directions
Adults and Children 2 years and older apply to affected area no more than 4 times daily,
Children under 2: Consult a doctor
Other Information
Store at room temperature
(Do not freeze)
Inactive Ingredients
Propylene glycol, Carbomer, Purified water.
Package Label.Principal Display Panel
Genuine Hydrocortisone CreamMaximum StrengthAnti-ItchNet Wt 0.9g (1/32 oz)Manufactured in CHINA for Genuine First Aid
Product Labeling
Genuine Hydrocortisone Cream (Hydrocortisonecream)
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