AVON HeXashield Athletes Foot Cream: Package Insert and Label Information

AVON HEXASHIELD ATHLETES FOOT CREAM- tolnaftate cream
Tai Guk Pharm. Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Tolnaftate 1 %

Purpose

Antifulgal

Uses

  • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

For external use only.

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

Do not use on children

  • under 2 years of age except under the advice and supervision of a doctor

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
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete’s foot, apply once or twice daily (morning and night)
  • this product is not effective on the scalp or nails

Other information

  • store at room temperature
  • Lot No. & Exp. Date: see box or crimp of tube

Inactive Ingredients

butylated hydroxytolune, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylparaben, sorbitan monostearate, stearyl alcohol, water

Questions or comments?

Call toll free 1-800-FOR-AVON

www.avon.com

Principal Display Panel

HeXasheild

Compare to the active ingredient in Tinactin®

Cures & Prevents Most Athlete’s Foot

AVON

EFFECTIVE TREATMENT OF:

– ATHLETE’S FOOT — JOCK ITCH — RINGWORM

HeXashield

ATHLETE’S FOOT CREAM

TOLNAFTATE 1% ANTIFUNGAL CREAM

NET WT 1 oz (28 g)

 AVON ATHLETES FOOT CREAM_1
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 AVON ATHLETES FOOT CREAM_DF
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AVON HEXASHIELD ATHLETES FOOT CREAM
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARYL ALCOHOL
WATER
BUTYLATED HYDROXYTOLUENE
SORBITAN MONOSTEARATE
CETETH-20
CETYL ALCOHOL
MINERAL OIL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43136-104-01 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (43136-104-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 07/31/2019
Labeler — Tai Guk Pharm. Co., Ltd. (689060246)
Establishment
Name Address ID/FEI Operations
Tai Guk Pharma. Co., Ltd. 689060246 manufacture (43136-104)

Revised: 07/2019 Tai Guk Pharm. Co., Ltd.

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