Butenafine Hydrochloride Cream
FDA Label NDC 49035-178

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Butenafine Hydrochloride (NDC 49035-178). 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, 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

DISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 72716

Active Ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most jock itch
  • relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

For external use only

Do Not Use

  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Otc - When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if too much irritation occurs or irritation gets worse

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

  • adults and children 12 years and older:
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • apply once a day to affected skin for 2 weeks or as directed by a doctor
    • wash hands after each use
    • children under 12 years: ask a doctor

Other Information

  • do not use if seal on tube is broken or not visible
  • store between 20° to 25° C (68° to 77° F)

Inactive Ingredients

Benzyl Alcohol, Cetyl Alcohol, Glycerin, Glyceryl Monostearate SE, Polyoxyethylene (23) Cetyl Ether, Propylene Glycol Dicaprylate, Purified Water, Sodium Benzoate, Stearic Acid, Trolamine, White Petrolatum

Questions?

1-888-287-1915

Principal Display Panel - 12 G Tube Carton

NDC 49035-178-08

equate™

Compare to Lotrimin Ultra® Jock Itch Active Ingredient*

CONTAINS THE DRUG:
BUTENAFINE HYDROCHLORIDE

Butenafine Hydrochloride Cream 1%
Antifungal

Clinically Proven To Cure Most Jock Itch

  • Prescription Strength
  • Relieves Itching, Burning and Chafing

    • NET WT
    0.42 OZ (12 g)

    Principal Display Panel (12 g Tube Carton)

    Principal Display Panel (12 g Tube Carton)

* Please review the disclaimer below.