Itch Fixer
FDA Label NDC 72663-493

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

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 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

Image (72663 493 66)

Image (72663 493 66)

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