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  5. Label Information: Antifungal Foot Treatment

FDA Label for Antifungal Foot Treatment

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Antifungal Foot Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Rida Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Butenafine hydrochloride 1%


Purpose



Antifungal


Uses



● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
● relieves itching, burning, cracking, and scaling which accompany these conditions


Warnings



For external use only


Do not use

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

    • When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.
    • Stop use and ask a doctor iftoo much irritation occurs or irritation gets worse
    • 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 over:
      ● wash the affected skin with the soap and water and dry completly before applying.
      ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.

      ● for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or          once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

  • Wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
  • wash hands after each use.

    • Childern under 12 years: ask a doctor


Other Information



● store between 20° to 25° C (68° to 77° F)


Inactive Ingredients



Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum


Product Label



image description - label1

image description - label1


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