FDA Label for Itch Fixer
View Indications, Usage & Precautions
Itch Fixer Product Label
The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. 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.
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
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.
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
• Do not use if pregnant or breastfeeding.
Directions
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.
Other Information
Store at a controlled room temperature 68°–77°F (20°–25°C).
Inactive Ingredients
Aqua, Aloe Vera Oil, Benzoic Acid, Cetostearyl Alcohol, Glyceryl Stearate, Jojoba Oil, Polysorbate 80, Oleyl Alcohol, Sorbic Acid, Sorbitan Monooleate
Packaging
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