Update-85398-018-01

Update-85398-018-01
SPL v2
SPL
SPL Set ID 4142f490-c4b5-a9f3-e063-6394a90ab75e
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.57 g)
Inactive Ingredients
Aloe Vera Leaf Juice Alcohol Polysorbate 80 Ethylparaben Glyceryl Stearate Dimethicone 6 Allantoin Glycerin Propylene Glycol Isohexadecane Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Potassium Alum Water Cocos Nucifera (coconut) Oil Stearic Acid Sodium Glutamate Sodium Myristate Myristic Acid Sodium Dodecylbenzenesulfonate Sorbitol Melaleuca Alternifolia (tea Tree) Leaf Oil Lauric Acid Sodium Hydroxide Hamamelis Virginiana Bark Olea Europaea (olive) Fruit Oil Elaeis Guineensis (palm) Oil Sulfur

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Soap Bar: Tolnaftate 1% Cream: Tolnaftate 1%


Medication Information

Warnings and Precautions

For external use only

Indications and 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.
Dosage and 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.
Description

Soap Bar: Tolnaftate 1% Cream: Tolnaftate 1%

Section 50565-1

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1
  • 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
Section 51727-6

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

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

Antifungal

Section 55106-9
  • Soap Bar: Tolnaftate 1%
  • Cream: Tolnaftate 1%
Section 60561-8

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)


Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)
  • 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 and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)
  • 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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit us at www.hermonhealth.com

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)
  • Soap Bar: Tolnaftate 1%
  • Cream: Tolnaftate 1%
Section 60561-8 (60561-8)

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)


Advanced Ingredient Data


Raw Label Data

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