SPL v2
SPL
SPL Set ID 752ef0cd-f12a-3b9e-e053-2991aa0abeb1
Route
TOPICAL
Published
Effective Date 2018-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor, (-)- (0.5 g) Menthol (1 g)
Inactive Ingredients
Fd&c Blue No. 1 Water Benzyl Alcohol Carbomer 934 Methylisothiazolinone Iodopropynyl Butylcarbamate Isopropyl Alcohol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-01
Description

Menthol 1 percent...............................................Topical Analgesic Camphor 0.5 percent.........................................Topical Analgesic

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 1 percent...............................................Topical Analgesic Camphor 0.5 percent.........................................Topical Analgesic

Uses:

for the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache, strains, sprains, sports injuries, arthritis, bruises

Section 51945-4

Directions
  • clean affected area before applying products
  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily
Do Not Use

with other topical pain relievers

with heating pads or heating devices

Drug Facts

Menthol 1 percent...............................................Topical Analgesic

Camphor 0.5 percent.........................................Topical Analgesic

When Using This Product:
  • Do not use in or near eyes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
Stop Use and Ask Doctor If:
  • Condition worsens, symptoms last more than 7 days or clear up and occur again within a few days
  • Redness or irritation develops
Warnings: External Use Only

For external use only.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Posion Control Center immediately.

Structured Label Content

Uses:

for the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache, strains, sprains, sports injuries, arthritis, bruises

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Directions
  • clean affected area before applying products
  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily
Do Not Use (Do not use)

with other topical pain relievers

with heating pads or heating devices

Drug Facts

Menthol 1 percent...............................................Topical Analgesic

Camphor 0.5 percent.........................................Topical Analgesic

When Using This Product: (When using this product:)
  • Do not use in or near eyes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
Stop Use and Ask Doctor If: (Stop use and ask Doctor if:)
  • Condition worsens, symptoms last more than 7 days or clear up and occur again within a few days
  • Redness or irritation develops
Warnings: External Use Only

For external use only.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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

If swallowed, get medical help or contact a Posion Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:20.862262 · Updated: 2026-03-14T23:01:22.645369