drug facts

drug facts

SPL v2

SPL

SPL Set ID f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea

Route

topical

Published

Effective Date 2019-12-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

menthol (1 g)

Inactive Ingredients

lanolin cocoa butter coconut oil grape seed oil peppermint oil croton lechleri resin tea tree oil

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2019-12-09

Purpose

External analgesic

Description

Menthol 1%

Medication Information

Purpose

External analgesic

Directions

Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.

Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Inactive Ingredients

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil

Description

Menthol 1%

Packaging

Active Ingredients

Menthol 1%

Structured Label Content

Purpose

External analgesic

Directions

Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.

Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Inactive Ingredients

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil

Packaging

Active Ingredients (Active ingredients)

Menthol 1%

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GRAPE SEED OIL", "unii": "930MLC8XGG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROTON LECHLERI RESIN", "unii": "GGG6W25C63", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Purpose": "External analgesic", "Directions": "Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.", "Other Information": "Store at room temperature 68 to 77°F (20 to 25ºC).", "Active ingredients": "Menthol 1%", "Inactive Ingredients": "Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:52.610920 · Updated: 2026-03-14T22:58:41.209834