1994356c-e347-5b7d-e063-6394a90a476c

SPL v1
SPL
SPL Set ID 1994356c-e347-5b7d-e063-6394a90a476c
Route
topical
Published
Effective Date 2017-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (1.25 g)
Inactive Ingredients
sodium hydroxide propylene glycol hydrogenated castor oil butylated hydroxytoluene water fd&c blue no. 1 camphor (synthetic) benzyl alcohol edetate disodium carbomer 934 isopropyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-01

Purpose

Topical analgesic

Description

Menthol 1.25%


Medication Information

Warnings

For external use only.

Do not use: with other topical pain relievers, with heating pads or heating devices.

Uses

temporarily relieves minor muscle aches and pains of muscles and joints associated with:

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

Purpose

Topical analgesic

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.

chidlren under 2 years of age: ask a doctor.

Other Information

store at controlled room temperature 20 to 25℃ (68 to 77°F) 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 oil, propylene glycol, sodium hydroxide, water

Description

Menthol 1.25%

Section 51945-4

Active Ingredient

Menthol 1.25%

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.

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 Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Do not use: with other topical pain relievers, with heating pads or heating devices.

Uses

temporarily relieves minor muscle aches and pains of muscles and joints associated with:

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

Purpose

Topical analgesic

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.

chidlren under 2 years of age: ask a doctor.

Other Information (Other information)

store at controlled room temperature 20 to 25℃ (68 to 77°F) in a tightly closed container.

do not use, pour, spill or store near heat or open flame.

Inactive Ingredients (Inactive ingredients)

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

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Menthol 1.25%

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.

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 Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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