Miconazole Nitrate Cream
FDA Label NDC 70677-1000

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 Miconazole Nitrate (NDC 70677-1000). 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

Miconazole nitrate USP 2%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions

Warnings

For external use only

Otc - Do Not Use

Do not use on children less than 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
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks

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. (1-800-222-1222)

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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 the 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
  • 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 on cap to puncture seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton flap or tube crimp for lot number and expiration date

Inactive Ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

Questions?

call 833-358-6431

Principal Display Panel - 30 G Tube Carton

Foster & Thrive™

Antifungal Cream

Miconazole Nitrate Cream USP, 2%
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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