Atopalm Clotrimazole Antifungal
FDA Label NDC 51141-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Atopalm Clotrimazole Antifungal (NDC 51141-100). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

US Patent US 6221371B1

Distributed by: NeoPharm Co., Ltd, 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

Clotrimazole 1%AntifungalCream

Otc - Active Ingredient

Active Ingredients

Clotrimazole 1%

Otc - Purpose

Purpose

Antifungal

Indications & Usage

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings

Warnings       For external use only.

Otc - Do Not Use

Do not use on diaper rash or on children under 2 years of age unless directed by a doctor.


Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day.
  • for athlete's foot and ringworm, use daily for 4 weeks, for jock itch use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product not effective on the scalp or nails

Storage And Handling

Other Information

  • store at 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
  • see end of carton or tube crimp for lot number and expiration date

Inactive Ingredient

Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

Otc - Questions

Questions? Call 1-855-ATOPALM

Product Labeling

Image Description (Ato Antifungalc)

Image Description (Ato Antifungalc)


Image Description (Ato Antifungalcbox)

Image Description (Ato Antifungalcbox)

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