lubracane

lubracane
SPL v8
SPL
SPL Set ID 7c503e3e-1987-4027-8a43-12acf2cb548a
Route
topical
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.24 mg)
Inactive Ingredients
dimethyl sulfone carbomer interpolymer type a (allyl sucrose crosslinked) diazolidinyl urea polysorbate 20 ammonia water propylene glycol iodopropynyl butylcarbamate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-01-15

Description

Menthol 0.24% Topical Analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes and open wounds. Do not use if allergic to any of its ingredients.

​Keep out of reach of children.​ If swallowed, get medical help or contact Poison Control immediately.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis and minor injuries including sprains, strains and bruises.

Indications and Usage

Directions

Adults and Children over 12.Apply an adequate amount of gel to cover affected area. On day 1 apply 2 to 3 times within the first hour, and up to six times that day. On the following days, apply 3 to 4 times a day, as needed. 

Other Information

Store between 68° and 74°F (20°-23°C) with closed cover. Do not apply with hot pack. 

Inactive Ingredients

Filtrated deionized water, MethylSulfonylMethane (MSM), Acrylates/C-10-30, Alkyl Acrylate Crosspolymer, Polysorbate-20, Propylene Glycol (and) Dizolidinyl Urea (and) Iodopropynyl Butylcarbamate, Ammonium Hydroxide. 

Description

Menthol 0.24% Topical Analgesic

Label 

Do Not Use

If pregnant, breast feeding or intending to become pregnant.

Precautions

Stop use and consult a physician if pain persists beyond 3 days, a rash or irritation develops, or if condition worsens, or resolves and then returns. 

Active Ingredients

Menthol 0.24% Topical Analgesic

Questions Or Comments

Email us at: [email protected]


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes and open wounds. Do not use if allergic to any of its ingredients.

​Keep out of reach of children.​ If swallowed, get medical help or contact Poison Control immediately.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis and minor injuries including sprains, strains and bruises.

Indications and Usage (34067-9)

Directions

Adults and Children over 12.Apply an adequate amount of gel to cover affected area. On day 1 apply 2 to 3 times within the first hour, and up to six times that day. On the following days, apply 3 to 4 times a day, as needed. 

Other Information

Store between 68° and 74°F (20°-23°C) with closed cover. Do not apply with hot pack. 

Inactive Ingredients

Filtrated deionized water, MethylSulfonylMethane (MSM), Acrylates/C-10-30, Alkyl Acrylate Crosspolymer, Polysorbate-20, Propylene Glycol (and) Dizolidinyl Urea (and) Iodopropynyl Butylcarbamate, Ammonium Hydroxide. 

Label 

Do Not Use

If pregnant, breast feeding or intending to become pregnant.

Precautions

Stop use and consult a physician if pain persists beyond 3 days, a rash or irritation develops, or if condition worsens, or resolves and then returns. 

Active Ingredients

Menthol 0.24% Topical Analgesic

Questions Or Comments (Questions or Comments)

Email us at: [email protected]


Advanced Ingredient Data


Raw Label Data

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