Theraplus Cream
FDA Label NDC 55621-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Theraplus (NDC 55621-003). 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 inactive ingredient, otc - active ingredient, warnings, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Inactive Ingredient

Inactive Ingredients glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water

Otc - Active Ingredient

Active Ingredient

Clotrimazole 1%

Warnings

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

on the scalp or nails

When using this product

avoid contact with eyes

Otc - Purpose

Purpose

Antifungal

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

Indications & Usage

Uses  relieves itching, burning, cracking, scaling and discomfort associated with:

-athletes foot      -jock itch      -ring worm


Dosage & Administration

Directions

-wash and dry affected area thoroughly

-apply a thin layer to affected area 2 times daily

-for athlete's foot and ringworm, use daily for up to 4 weeks

-for jock itch, use daily for up to 2 weeks

Package Label.Principal Display Panel

Copy Of Label (Zhejiang Antifungal)

Copy Of Label (Zhejiang Antifungal)

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