Drug Facts
Active Ingredients
Hydrocortisone 1%
Active Ingredients....................................................Purpose
Hydrocortisone 1%..................................................... Anti-itch
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Anti Itch (NDC 13709-326). 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 drug facts, uses, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, storage temperature, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Hydrocortisone 1%
Active Ingredients....................................................Purpose
Hydrocortisone 1%..................................................... Anti-itch
Uses: for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
■ eczema
■ insect bites
■ cosmetics
■ psoriasis
■ detergents
■ soaps
■ poison ivy, oak and sumac
■ jewelry
■ seborrheic dermatitis
■ temporarily relieves external anal and genital itching
■ other uses of this product should only be under the advice and supervision of a doctor
■ 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
Keep out of reach of children. If swallowed, get medical help or contact a Poison
■ 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 of age: ask a doctor
■ If pregnant or breast-feeding: ask a health professional before use.
■ for external anal and genital itching,
adults:
■ when practical, clean the affected area with mild soap and warm 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
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 of age: ask a doctor
■ If pregnant or breast-feeding: ask a health professional before use.
■ for external anal and genital itching, adults:
■ when practical, clean the affected area with mild soap and warm 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
not to exceed 30°C (86°F).
Protect from freezing.
■ Before using any medication, read all label directions.
Keep carton, it contains important information.
aloe vera leaf, avena sativa extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acrylodimethyl taurate copolymer, isohexadecane, maltodextrin, methyl gluceth-20, methyl lactate, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, purified water, SD alcohol,sodium citrate
TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
For external use only.
Do not use
■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash.
Consult a doctor.
* Please review the disclaimer below.