Human Science Muscle Pain Relief

Human Science Muscle Pain Relief
SPL v2
SPL
SPL Set ID 4bccc017-264b-11ce-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg) Menthol
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Carboxypolymethylene Citric Acid Monohydrate Orange Oil Dimethyl Sulfoxide Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Glycerin Isopropyl Alcohol Isopropyl Myristate Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-28

Description

Methyl Salicylate 10.00% Menthol 10.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 10.00% Menthol 10.00%

Uses:

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

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days,  discontinue use and consult physician.
Directions
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.
Do Not Apply 
  • to wounds or damaged skin.
  • Do not bandage tightly.
Active Ingredient

Methyl Salicylate 10.00%

Menthol 10.00%

Package Labeling:

Other Information:

Store at room temperature.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswellia Extract, Carbomer, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Dimethyl Sulfoxide (DMSO), Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Triethanolamine.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach of Children.
  • If swallowed, consult physician.

Structured Label Content

Uses:

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

Purpose

Topical Analgesic

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days,  discontinue use and consult physician.
Directions
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.
Do Not Apply  (Do not apply )
  • to wounds or damaged skin.
  • Do not bandage tightly.
Active Ingredient

Methyl Salicylate 10.00%

Menthol 10.00%

Package Labeling:

Other Information:

Store at room temperature.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswellia Extract, Carbomer, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Dimethyl Sulfoxide (DMSO), Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Triethanolamine.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

contact physician prior to use.

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, consult physician.

Advanced Ingredient Data


Raw Label Data

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