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SPL v4

SPL

SPL Set ID 58e1e7f7-6284-411f-9765-0e63eabca0f3

Route

topical

Published

Effective Date 2025-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

menthol (1 g)

Inactive Ingredients

starch, corn tricalcium phosphate sodium bicarbonate benzethonium chloride eucalyptus oil peppermint oil

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2018-06-01

Purpose

External Analgesic

Description

Menthol 1.0%

Medication Information

Warnings

For external use only

Uses

temporary relief of the pain and itch associated with:

minor cuts
sunburn
insect bites
scrapes
minor burns
minor skin irritations

Purpose

External Analgesic

Directions

Adults and children 2 years and older - apply freely upto 3 or 4 times daily
children under 2 years - ask a doctor before using

For best results, dry skin thoroughly before applying.

Inactive Ingredients

Zea Mays (Corn) Starch, Tricalcium Phosphate, Sodium Bicarbonate, Benzethonium Chloride, Eucalyptus Oil, Peppermint Oil

Description

Menthol 1.0%

Section 51945-4

Active Ingredient

Menthol 1.0%

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor If

condition worsens
symptoms persists for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses

temporary relief of the pain and itch associated with:

minor cuts
sunburn
insect bites
scrapes
minor burns
minor skin irritations

Purpose

External Analgesic

Directions

Adults and children 2 years and older - apply freely upto 3 or 4 times daily
children under 2 years - ask a doctor before using

For best results, dry skin thoroughly before applying.

Inactive Ingredients (Inactive ingredients)

Zea Mays (Corn) Starch, Tricalcium Phosphate, Sodium Bicarbonate, Benzethonium Chloride, Eucalyptus Oil, Peppermint Oil

Section 51945-4 (51945-4)

Active Ingredient

Menthol 1.0%

When Using This Product (When using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms persists for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRICALCIUM PHOSPHATE", "unii": "K4C08XP666", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporary relief of the pain and itch associated with: minor cuts sunburn insect bites scrapes minor burns minor skin irritations", "Purpose": "External Analgesic", "Warnings": "For external use only", "Directions": "Adults and children 2 years and older - apply freely upto 3 or 4 times daily children under 2 years - ask a doctor before using For best results, dry skin thoroughly before applying.", "Active Ingredient": "Menthol 1.0%", "Inactive ingredients": "Zea Mays (Corn) Starch, Tricalcium Phosphate, Sodium Bicarbonate, Benzethonium Chloride, Eucalyptus Oil, Peppermint Oil", "When using this product": "Avoid contact with eyes", "Stop use and ask a doctor if": "condition worsens symptoms persists for more than 7 days or clear up and occur again within a few days", "Keep out of reach of children": "In case of accidental ingestion, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.107024 · Updated: 2026-03-14T23:10:09.220745