Clotrimazole
FDA Label NDC 68927-3491

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pedifix for the product Clotrimazole (NDC 68927-3491). 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 warnings, active ingredient, inactive ingredients, purpose, otc - keep out of reach of children, directions, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

For external use only
Ask a doctor before use on children under 2 years of age
When using this product avoid contact with eyes
Stop use and ask doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)
If swallowed, get medical help or contact a poison control center immediately

Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Aqua, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea

Purpose

Anti-fungal

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Directions

Read all package directions and warnings before using:
Use only as directed
Clean the affected area with soap and warm water and dry throughly
Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor
This product is not effective on the scalp or nails
Avoid applying to severly cracked or irritated areas
For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated shoes and change shoes and socks at least once daily
For athlete's foot and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks
Supervise children in the use of this product
Intended foruse by normally healthy adults only
Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor.

Other Information

Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

Package Label.Principal Display Panel

Image Description (Zbox R3491 Org414)

Image Description (Zbox R3491 Org414)

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