Active Ingredient
Hydrocortisone 1%
The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Itch Fixer (NDC 72663-493). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Hydrocortisone 1%
Anti-itch
For temporary relief of itching associated with minor skin irritations and rashes due to • eczema • insect bites • poison ivy • poison oak
• poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital and anal itching.
• Other uses of this product should be only under the advice and supervision of a doctor.
For external use only.
Do not use: • for the treatment of diaper rash • for external genital itching – if you have a vaginal discharge, consult a doctor.
When using this product • avoid contact with eyes • do not begin the use of any other hydrocortisone product unless
you have consulted a doctor • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed
by a doctor. In case of bleeding, stop use, consult a doctor • do not put this product into the rectum by using fingers or any mechanical device or
applicator.
Stop use and ask a doctor if • condition worsens • If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of
this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Keep out of the reach of children.
• Do not use if pregnant or breastfeeding.
Adults and children 2 years and older: • apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age • do not use. Consult a doctor. For external anal itching
• Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet
tissue or a soft cloth before application of this product.
• Children under 12 years with external anal itching: consult a doctor.
Store at a controlled room temperature 68°–77°F (20°–25°C).
Aqua, Aloe Vera Oil, Benzoic Acid, Cetostearyl Alcohol, Glyceryl Stearate, Jojoba Oil, Polysorbate 80, Oleyl Alcohol, Sorbic Acid, Sorbitan Monooleate
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