AVON HEXASHIELD ATHLETES FOOT CREAM- tolnaftate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
Tai Guk Pharm. Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifulgal - 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
Authorization status:
OTC monograph final
Authorization number:
43136-104-01

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.

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AVON HeXashield Althlete's Foot Cream

Active Ingredient

Tolnaftate 1 %

Purpos e

Antifulgal

Us es

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

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 HEXASHIELD ATHLETES FOOT CREAM

tolnaftate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43136 -10 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

CETETH-2 0 (UNII: I8 35H2IHHX)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

MINERAL O IL (UNII: T5L8 T28 FGP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Tai Guk Pharm. Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43136 -10 4-0 1

1 in 1 CARTON

0 7/31/20 19

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

0 7/31/20 19

Labeler -

T ai Guk Pharm. Co., Ltd. (689060246)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tai Guk Pharma. Co ., Ltd.

6 8 9 0 6 0 246

ma nufa c ture (43136 -10 4)

Revised: 7/2019

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