Lavinso Athlete’s Foot Antifungal Spray – Labeling

Lavinso Athlete’s Foot Antifungal Spray – Labeling
SPL v3
SPL
SPL Set ID 3cb9f025-79bf-7422-e063-6294a90ae609
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Citric Acid Phenoxyethanol Ethylhexylglycerin Peg-40 Hydrogenated Castor Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Aloe Barbadensis Leaf Juice Water Sodium Citrate Alcohol Peppermint Oil Propylene Glycol Eucalyptus Globulus Leaf Oil Lavender Oil Menthol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-17

Description

Active ingredient Tolnaftate 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

• Cures most athlete’s foot (tinea pedis) and jock itch (tinea cruris)

• Helps prevent most athlete’s foot with daily use

• Relieves itching, burning, cracking and scaling associated with these conditions

Description

Active ingredient Tolnaftate 1%

Section 44425-7

Other information

• Store at 59–86 °F (15–30 °C)

• Safety sealed: do not use if shrink-band around cap is broken or missing

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

• Irritation occurs

• There is no improvement within 4 weeks (athlete’s foot) or 2 weeks (jock itch)

Section 50567-7

When using this product

• Avoid contact with eyes

• Use only as directed

Section 50570-1

Do not use

• On children under 2 years of age unless directed by a doctor

Section 51727-6

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Denatured Alcohol 40-B, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Lavender Oil, Menthol, PEG-40 Hydrogenated Castor Oil, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium Citrate, Tea Tree Leaf Oil.

Section 51945-4

ATHLETE’S FOOT

ANTIFUNGAL SPRAY

Tolnaftate 1%

Cures & prevents most athlete’s foot

Fast-dry, cooling botanical formula

118 ML / 4.0 FL OZ

Designed in USA

Distributed by

Lavinso Trading LLC

300 Sunny Isles Blvd, Unit 1204

Sunny Isles Beach, FL 33160 USA

Made in India

NDC 87011-101

Batch No

Exp Date



Section 53413-1

Questions?

Email us at [email protected] or visit lavinso.com

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Tolnaftate 1%

Section 59845-8

Directions

• Clean and dry the affected area

• Shake well before use. Spray a thin layer twice daily (morning and night)

• For athlete’s foot, pay special attention to spaces between the toes

• Use daily for 4 weeks for athlete’s foot; 2 weeks for jock itch

• To help prevent athlete’s foot, apply once daily

• Keep feet dry; change socks daily. Supervise children in use

• Not effective on scalp or nails

When Using This Product

• Avoid contact with eyes

• Use only as directed


Structured Label Content

Indications and Usage (34067-9)

Uses

• Cures most athlete’s foot (tinea pedis) and jock itch (tinea cruris)

• Helps prevent most athlete’s foot with daily use

• Relieves itching, burning, cracking and scaling associated with these conditions

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

• Store at 59–86 °F (15–30 °C)

• Safety sealed: do not use if shrink-band around cap is broken or missing

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• Irritation occurs

• There is no improvement within 4 weeks (athlete’s foot) or 2 weeks (jock itch)

Section 50567-7 (50567-7)

When using this product

• Avoid contact with eyes

• Use only as directed

Section 50570-1 (50570-1)

Do not use

• On children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Denatured Alcohol 40-B, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Lavender Oil, Menthol, PEG-40 Hydrogenated Castor Oil, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium Citrate, Tea Tree Leaf Oil.

Section 51945-4 (51945-4)

ATHLETE’S FOOT

ANTIFUNGAL SPRAY

Tolnaftate 1%

Cures & prevents most athlete’s foot

Fast-dry, cooling botanical formula

118 ML / 4.0 FL OZ

Designed in USA

Distributed by

Lavinso Trading LLC

300 Sunny Isles Blvd, Unit 1204

Sunny Isles Beach, FL 33160 USA

Made in India

NDC 87011-101

Batch No

Exp Date



Section 53413-1 (53413-1)

Questions?

Email us at [email protected] or visit lavinso.com

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Tolnaftate 1%

Section 59845-8 (59845-8)

Directions

• Clean and dry the affected area

• Shake well before use. Spray a thin layer twice daily (morning and night)

• For athlete’s foot, pay special attention to spaces between the toes

• Use daily for 4 weeks for athlete’s foot; 2 weeks for jock itch

• To help prevent athlete’s foot, apply once daily

• Keep feet dry; change socks daily. Supervise children in use

• Not effective on scalp or nails

When Using This Product (When using this product)

• Avoid contact with eyes

• Use only as directed


Advanced Ingredient Data


Raw Label Data

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