SPL v1
SPL
SPL Set ID 4f92baf8-0087-4637-9881-55ca0444b12f
Route
TOPICAL
Published
Effective Date 2010-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Carbomer Homopolymer Type C Fd&c Blue No. 1 Isopropyl Alcohol Propylene Glycol Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-06-15
Description

Active Ingredient Menthol 2.0%

Medication Information

Warnings and Precautions

Warning

For external use only. Avoid contact with eyes

Indications and Usage

Uses

Temporary relief of minor pains of muscles and joints associated with

  • Simple back ache

  • Arthritis
  • Sprains, strains or bruises

Description

Active Ingredient Menthol 2.0%

Section 42229-5
Other Information store between 59-85F (15-30C)

  • Keep tightly closed
  • Do not use, pour, spill or store near heat or open flames

Section 50565-1
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

Section 50567-7
When using this product
  • Use only as directed

  • Do not bandage tightly
  • Avoid contact with eyes and mucus membranes

Section 50569-3

Ask doctor before use if you have sensitive skin

Section 50570-1

Do not use

  • Internally
  • With heating pads or devices
  • On wounds or damaged skin

Section 51727-6
Other Ingredients Carbomer 940, FDC Blue No. 1, Isopropyl Alcohol, Propylene Glycol, Purified Water, Sodium Hydroxide,



Section 51945-4

Package Label

Section 53414-9
If pregnant or breast feeding, ask a health professional before use

Section 55105-1

Purpose

External pain reliever

Section 55106-9

Active Ingredient

Menthol 2.0%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of minor pains of muscles and joints associated with

  • Simple back ache

  • Arthritis
  • Sprains, strains or bruises

Warnings and Precautions (34071-1)

Warning

For external use only. Avoid contact with eyes

Section 42229-5 (42229-5)
Other Information store between 59-85F (15-30C)

  • Keep tightly closed
  • Do not use, pour, spill or store near heat or open flames

Section 50565-1 (50565-1)
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

Section 50567-7 (50567-7)
When using this product
  • Use only as directed

  • Do not bandage tightly
  • Avoid contact with eyes and mucus membranes

Section 50569-3 (50569-3)

Ask doctor before use if you have sensitive skin

Section 50570-1 (50570-1)

Do not use

  • Internally
  • With heating pads or devices
  • On wounds or damaged skin

Section 51727-6 (51727-6)
Other Ingredients Carbomer 940, FDC Blue No. 1, Isopropyl Alcohol, Propylene Glycol, Purified Water, Sodium Hydroxide,



Section 51945-4 (51945-4)

Package Label

Section 53414-9 (53414-9)
If pregnant or breast feeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

External pain reliever

Section 55106-9 (55106-9)

Active Ingredient

Menthol 2.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.023291 · Updated: 2026-03-14T22:52:24.761203