HERMON ATHLETES FOOT TOLNAFTATE 1% KIT- tolnaftate 1% kit kit

Hermon Athletes foot Tolnaftate 1% kit by

Drug Labeling and Warnings

Hermon Athletes foot Tolnaftate 1% kit by is a Otc medication manufactured, distributed, or labeled by Beautivity LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Soap Bar: Tolnaftate 1%
• Cream: Tolnaftate 1%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

• cures most athlete's foot (tinea pedis)
• cures most jock itch(tinea cruris) and ringworm (tinea corporis)
• relieves itching, burning, cracking and scaling which accomppany these conditions
• For effective relief of itching, cirritation, redness, scaling, cracking, burning, soreness, anddiscomfort which can accompany these conditions.

WARNINGS

For external use only

• on children under 2 years of age unless directed by a doctor.
• On nails or scalp
• in or near the mouth or eyes
• for vaginal yeast infections

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

if irritation occurs or there is no improvement within 2 wveeks.

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

INDICATIONS & USAGE

Directions (Cream)

• adults and children 12 years and over
• use the tip of thecap to break the seal and open the tube
• wash the affedted 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 ttoes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
• on the bottom or sides ofthe foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
• for jock itch and ringworm: apply oncea day (morning or night) for 1 week or as directed by a doctor
• wash hands after each use
• children under 12 years: ask a doctor
• 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
• use daily for2 weeks

Directions (Soap Bar)

• Wet skin with warm water and lather soap.
• Gently massage onto affeected areas.
• Rinse thoroughly and dry.
• Use twice daily or as directed by a doctor.

OTHER SAFETY INFORMATION

Do not use if seal on tube is broken or is not visible. Store at room temperature. Protect from excessive heat(above 104°F/40°C)

INACTIVE INGREDIENT

Cream:

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyc Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurrate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice

Soap Bar:

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorlbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glyceerin, Stearic Acid, Lauric Acid, Myristic Acid, Šodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

QUESTIONS

visit us at www.hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERMON ATHLETES FOOT TOLNAFTATE 1% KIT 
tolnaftate 1% kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-018

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-018-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	10/31/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 CARTON	1 g  in 116
Part 2	1 TUBE	57 g

Part 1 of 2

ATHLETE FOOT MEDICATED BAR 
tolnaftate soap

Product Information
Item Code (Source)	NDC: 85398-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.16 g  in 116 g

Inactive Ingredients
Ingredient Name	Strength
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SULFUR (UNII: 70FD1KFU70)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
MYRISTIC ACID (UNII: 0I3V7S25AW)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
LAURIC ACID (UNII: 1160N9NU9U)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-007-02	116 g in 1 CARTON; Type 0: Not a Combination Product

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

Part 2 of 2

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

Product Information
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	0.57 g  in 57 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-017-02	57 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 Drug	M005	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)