SPL v1
SPL
SPL Set ID 7769ca14-3159-4bfa-e053-2a91aa0a65f1
Route
TOPICAL
Published
Effective Date 2018-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Carboxypolymethylene Cupric Sulfate Magnesium Sulfate, Unspecified Thymol Fd&c Blue No. 1 Isopropyl Alcohol Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-10-01

Description

Menthol 2%

Purpose

Topical Analgesic


Medication Information

Purpose



Topical Analgesic

Description

Menthol 2%

Uses

For the temporary relief of monor aches and pains in muscles and joints associated with:



■ simple backache

■ sprains

■ arthritis

■ strains

■ sports injuries

■ bruises

Warnings

For external use only

Directions

■ clean affected area before applying product ■ 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

Package Label

Active Ingredient

Menthol 2%

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, water

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 A Doctor If

■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of monor aches and pains in muscles and joints associated with:



■ simple backache

■ sprains

■ arthritis

■ strains

■ sports injuries

■ bruises

Purpose



Topical Analgesic

Warnings

For external use only

Directions

■ clean affected area before applying product ■ 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

Package Label

Active Ingredient (Active ingredient)

Menthol 2%

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, water

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

■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

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)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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