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SPL v1

SPL

SPL Set ID f8b5525c-b4bf-d2ee-e053-6394a90a61c5

Route

TOPICAL

Published

Effective Date 2023-04-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (1.2 g) Garlic Oil (7.5 g)

Inactive Ingredients

Allantoin Butylene Glycol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2023-04-07

Description

menthol, garlic oil

Medication Information

Warnings and Precautions

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

red specks, swelling, itching

■ don’t use on the part where there is injury, eczema, or dermatitis

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

Indications and Usage

shake the container for 2 to 3 times before use, apply it evenly

Dosage and Administration

for external use only

Description

menthol, garlic oil

Section 50565-1

Keep out of reach of children

Section 51727-6

purified water

Batylene Glycol

allantoin

SODIUMHYALURONATE

Solubiliser

1.2Hexanediol

Vitamin E

Carbomer

DisodiumEDTA

TEA TREE oil

citrus junos seed oil

Avandula Angustifolia(Lavander) oil

Section 51945-4

Section 55105-1

digestion

Section 55106-9

menthol, garlic oil

Structured Label Content

Indications and Usage (34067-9)

shake the container for 2 to 3 times before use, apply it evenly

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

red specks, swelling, itching

■ don’t use on the part where there is injury, eczema, or dermatitis

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

purified water

Batylene Glycol

allantoin

SODIUMHYALURONATE

Solubiliser

1.2Hexanediol

Vitamin E

Carbomer

DisodiumEDTA

TEA TREE oil

citrus junos seed oil

Avandula Angustifolia(Lavander) oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

digestion

Section 55106-9 (55106-9)

menthol, garlic oil

Advanced Ingredient Data

[{"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GARLIC OIL", "unii": "4WG8U28833", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "shake the container for 2 to 3 times before use, apply it evenly", "34068-7": "for external use only", "34071-1": "■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist red specks, swelling, itching ■ don’t use on the part where there is injury, eczema, or dermatitis Keep out of reach of children ■ if swallowed, get medical help or contact a person control center immediately", "50565-1": "Keep out of reach of children", "51727-6": "purified water Batylene Glycol allantoin SODIUMHYALURONATE Solubiliser 1.2Hexanediol Vitamin E Carbomer DisodiumEDTA TEA TREE oil citrus junos seed oil Avandula Angustifolia(Lavander) oil", "55105-1": "digestion", "55106-9": "menthol, garlic oil"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:39.211359 · Updated: 2026-03-14T23:01:08.226420