SPL v1
SPL
SPL Set ID 6a37570e-c41b-d091-e053-2991aa0acbb9
Route
TOPICAL
Published
Effective Date 2018-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Propylene Glycol Benzyl Alcohol Butylated Hydroxytoluene Carboxypolymethylene Edetate Disodium Fd&c Blue No. 1 Isopropyl Alcohol Polyoxyl 40 Hydrogenated Castor Oil Sodium Hydroxide Water Camphor (synthetic)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-02

Description

Menthol 1.25%

Purpose

Topical Analgesic


Medication Information

Purpose



Topical Analgesic

Description

Menthol 1.25%

Uses

■ temporarily relieves minoraches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

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 ■ children under 2 years of age: ask a doctor

Do Not Use

■ with other topical relievers ■ with heating pads or heating devices

Package Label

Active Ingredient

Menthol 1.25%

Other Information

■ stroe at controlled room temperature 20 to 25 ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water

When Using This Product

■ do not use in or near the eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

■ temporarily relieves minoraches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

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 ■ children under 2 years of age: ask a doctor

Do Not Use (Do not use)

■ with other topical relievers ■ with heating pads or heating devices

Package Label

Active Ingredient (Active ingredient)

Menthol 1.25%

Other Information (Other information)

■ stroe at controlled room temperature 20 to 25 ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water

When Using This Product (When using this product)

■ do not use in or near the 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 more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

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

If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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