FDA Label for Hydrocortisone Anti-itch
View Indications, Usage & Precautions
Hydrocortisone Anti-itch Product Label
The following document was submitted to the FDA by the labeler of this product Anicare Pharmaceuticals Pvt. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Hydrocortisone 1%
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses
for the temporary relief of itching associated with minor skin irritations and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external genital, feminine and anal itching
Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use in genital area if you have a vaginal discharge.
Consult a doctor, for the treatment of diaper rash. Ask a doctor.
Otc - When Using
When using this product
- Avoid contact with eyes
- Do not use more than directed unless told to do so by a doctor
- Do not put directly into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor if
condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
For itching of skin irritation, inflammation, and rashes:
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: Ask a doctor
For external anal and genital itching, adults:
When practical, clean the affected area with mild soap and water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.
Other
Other information
- Store at 20°C to 25° C (68°F to 77° F)
- Lot No. & Exp. Date: see crimp of tube
Inactive Ingredient
Inactive Ingredients
Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
HYDROCORTISONE ANTI-ITCH CREAM
NET WT 0.5 OZ. (14 g)
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