INITIAL DRUG LISTING - HERMON ATHLETES FOOT 1% TOLNAFTATE CREAM- tolnaftate 1% cream

Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream by

Drug Labeling and Warnings

Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream by is a Otc medication manufactured, distributed, or labeled by Beautivity LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

• cures most athlete's foot (tinea pedis)
• cures most jock itch (tinea crurs) and ringworm(tinea corporis)
• relieves itching, burning, cracking and scaling which accompany these conditions

WARNINGS

FOR EXTERNAL USE ONLY

• on nails or scalp
• in or near themouth or eyes
• for vaginal yeast infections

do not get into eyes. lf eye contact occurs, rinse thoroughly with water

if too much irritationo ccurs or gets worse

lf swallowed, call a poison control centre or get medical help right away.

INDICATIONS & USAGE

• adults and children 12 years and over
• use the tip of the cap to break the seal and open the tube
• wash the affected skin with soap and water and dry completely before applying
• for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily
• between the toesonly: apply twice a day(morning and night) for 1week or as directed by a doctor
• on the bottomor sides of the foot: apply twice a day(morningand night)for 2 weeks or as directed by a doctor
• for jock itch and ringworm: apply once a day(morning or night) for 1 week or as directed by adoctor
• wash hands after each use
• children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

• Do not use if seal on tube is broken or is not visible.
• Store at 68-77°F(20-25°C)

INACTIVE INGREDIENT

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol, Ethoxylate,Alumen, Sodium Acrylate/Sodium, Acryloyldimethyl Taurate Copolymer, lsohexadecane,Polysorbate 80, Aloe Barbadensis Leaf Juice

QUESTIONS

service@hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INITIAL DRUG LISTING - HERMON ATHLETES FOOT 1% TOLNAFTATE CREAM 
tolnaftate 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.6 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM ALUM (UNII: 1L24V9R23S)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALLANTOIN (UNII: 344S277G0Z)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE 6 (UNII: RB8V8W9FQN)
ETHYLPARABEN (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-017-01	60 g in 1 CARTON; Type 0: Not a Combination Product	10/31/2025
2	NDC: 85398-017-02	57 g in 1 TUBE; Type 0: Not a Combination Product	10/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/31/2025

Labeler - Beautivity LLC (096573788)

Registrant - Beautivity LLC (096573788)