Active Ingredient
Hydrocortisone acetate (equivalent to Hydrocortisone 1%)
Genuine Hydrocortisone
FDA Label NDC 52124-2903
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, Llc for the product Genuine Hydrocortisone (NDC 52124-2903). 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, directions, other information, inactive ingredients, 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.
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.
Keep Out Of Reach Of Children
If ingested, get medical help or contact a Poison Control Center immediately.
Other
GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road,
Tong'an, Xiamen, Fujian, China 361100
Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street
LONDON W1G 9QR, England, United Kingdom
Copyright (c) 2010 GFA Production Xiamen Co., Ltd
All rights reserved
Package Label.Principal Display Panel
Genuine Hydrocortisone Cream
Maximum Strength
Anti Itch
Active ingredient:
Hydrocortisone Acetate
(equivalent to Hydrocortisone 1%)
Genuine Hydrocortisone Cream (Individual)
Genuine Hydrocortisone Cream- Box (Hydrocortisone Box)
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