TOLNAFTATE- athlete foot 2 way spray aerosol, spray

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

Warnings

For external use only.

Extremely flammable:

Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting. Use only as directed. Intentional misuses by deliberately concentrating and inhaling the contents can be harmful or fatal.

When using this product

• avoid contact with the eyes or mouth

Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks

Do not use

on children under 2 years of age unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well before use
• wash affected area and dry thoroughly
• hold can 4-6 inches away from affected area
• spray a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• 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 for athlete's foot and ringworm
• if condition persists longer, consult a doctor
• this product is not effective on the scalp or nails
• if nozzle clogs, clean with a pin

Other information

• store between 20° and 30°C (68° and 86°F)
• for targeted application between toes, rotate straw 180° and lock in place
• for all-over application, keep straw in a locked position

Inactive ingredients

SD alcohol 40, isobutane, PPG-12-buteth-16, water, butylene glycol, butane, butyrospermum parkii (shea) butter, BHT, soyethyl morpholinium ethosulfate, quaternium-91, cetrimonium methosulfate, cetearyl alcohol, sodium bicarbonate, sorbitan stearate, sorbityl laurate, glycerin, dimethicone

Questions?

Call 1-888-964-0939

Monday - Friday 8 AM-4:30 PM EST

www.armandhammerfootcare.com

Principal Display Panel

TOLNAFTATE ANTIFUNGAL

NEW!

ARM & HAMMER

PREVENTS & RELIEVES

ATHLETE'S FOOT

2-WAY SPRAY

BETWEEN TOES FULL FOOT

Provides Prevention & Relief for

Athlete's Foot, Itching & Burning

Clear Spray with Shea Butter

Moisturizes & Soothes

Dry, Cracked Feet

NET WT. 4.0 OZ (113 g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
athlete foot 2 way spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.3 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
CETRIMONIUM METHOSULFATE (UNII: 277IG2X9QC)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
QUATERNIUM-91 (UNII: 00J8H295NB)
SORBITYL LAURATE (UNII: 23XPH3M9LR)
ISOBUTANE (UNII: BXR49TP611)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-028-40	113 g in 1 CANISTER; Type 0: Not a Combination Product	04/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/15/2018

Labeler - Premier Brands of America (080051232)