MedPath

Lavinso Athlete Foot

Lavinso Athlete’s Foot Antifungal Spray – Labeling

Approved
Approval ID

3cb9f025-79bf-7422-e063-6294a90ae609

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Lavinso Trading LLC

DUNS: 064492110

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolnaftate Topical Spray

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87011-101
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate Topical Spray
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (15)

CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
PEG-40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
TOLNAFTATEActive
Quantity: 10 mg in 1 mL
Code: 06KB629TKV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EUCALYPTUS GLOBULUS LEAF OILInactive
Code: 2R04ONI662
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

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

Box

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active ingredient
Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose
Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings
For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

Do not use
• On children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

When using this product
• Avoid contact with eyes
• Use only as directed

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop use and ask a doctor if
• Irritation occurs
• There is no improvement within 4 weeks (athlete’s foot) or 2 weeks (jock itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 9/30/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/30/2025

Other information
• Store at 59–86 °F (15–30 °C)
• Safety sealed: do not use if shrink-band around cap is broken or missing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/30/2025

Questions?
Email us at info@lavinso.com or visit lavinso.com

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

When using this product

• Avoid contact with eyes
• Use only as directed

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