AVON HEXASHIELD ATHLETES FOOT CREAM- tolnaftate cream

AVON HeXashield Athletes Foot by

Drug Labeling and Warnings

AVON HeXashield Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Tai Guk Pharm. Co., Ltd., Tai Guk Pharma. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

AVON HEXASHIELD ATHLETES FOOT  CREAM
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43136-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43136-104-01	1 in 1 CARTON	07/31/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
Tai Guk Pharma. Co., Ltd.		689060246	manufacture(43136-104)