Muscle Rub Cream

Muscle Rub Cream
SPL v5
SPL
SPL Set ID 44d3638d-f29b-0e01-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.1 g) Salicylic Acid (0.15 g)
Inactive Ingredients
Polysorbate 80 Trolamine Propylparaben Carbomer 940 Cetyl Alcohol Glyceryl Monostearate Methylparaben Water Stearic Acid Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-29

Description

Menthol 10%


Medication Information

Indications and Usage

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

Description

Menthol 10%

Section 55105-1

Topical Analgesic

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Ask a doctor before use if you are pregnant or breast feeding.

When using this product

  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly
Packaging

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Distributed By

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Active Ingredient

Menthol 10%

Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-888-296-9067

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Stop Use and Ask A Doctor
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Indications and Usage (34067-9)

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

Section 55105-1 (55105-1)

Topical Analgesic

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Ask a doctor before use if you are pregnant or breast feeding.

When using this product

  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly
Packaging

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Distributed By

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Active Ingredient

Menthol 10%

Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-888-296-9067

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Stop Use and Ask A Doctor (Stop Use and ask a doctor)
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

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

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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