drug facts

drug facts
SPL v6
SPL
SPL Set ID d4119f84-eb60-4134-b58e-de13d9601199
Route
topical
Published
Effective Date 2013-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g) salicylic acid (15 g)
Inactive Ingredients
laureth-23 methylparaben mineral oil propylene glycol propylparaben stearic acid stearyl alcohol trolamine water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-03-01

Description

   carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

-on wounds or damaged skin -with a heating pad   - on a child under 12 years of age with arthritis-like condition

When using this product

-avoid contact with eyes and mucous membranes      -do not bandage tightly

Active Ingredient

Active Ingredient

Menthol 10%

Menthol salicylate 15%

Indications and Usage

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

-simple backache   -arthritis   -bruises   -strains   -sprains

Dosage and Administration

Directions

-adults and children 12 years of age and older:  apply to all affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Description

   carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 50565-1

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

Section 51727-6

   carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 51945-4

Section 55105-1

Purpose

Topical analgesic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

-on wounds or damaged skin -with a heating pad   - on a child under 12 years of age with arthritis-like condition

When using this product

-avoid contact with eyes and mucous membranes      -do not bandage tightly

Active Ingredient (55106-9)

Active Ingredient

Menthol 10%

Menthol salicylate 15%

Indications and Usage (34067-9)

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

-simple backache   -arthritis   -bruises   -strains   -sprains

Dosage and Administration (34068-7)

Directions

-adults and children 12 years of age and older:  apply to all affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

   carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic


Advanced Ingredient Data


Raw Label Data

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