Clotrimazole 1% Cream
FDA Label NDC 70677-1002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Clotrimazole 1% (NDC 70677-1002). 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, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

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

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

When using this product avoid contact with the eyes.

Stop Use And Ask A Doctor If

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

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.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated 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
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

call 833-358-6431

Principal Display Panel - 30 G Tube Carton

Foster & Thrive™

Athlete's Foot Cream

Clotrimazole Cream USP, 1%
ANTIFUNGAL

NET WT 1 OZ (30 g)

Principal Display Panel (30 g Tube Carton)

Principal Display Panel (30 g Tube Carton)

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