active and innovative (as pld) - musclecare roll-on

active and innovative (as pld) - musclecare roll-on
SPL v4
SPL
SPL Set ID 1755ec89-c404-1c17-e063-6394a90ab9fb
Route
topical
Published
Effective Date 2024-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (4 g) menthol (10 g)
Inactive Ingredients
alcohol starch, corn eucalyptus globulus leaf acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) dimethyl sulfone glycerin aminomethylpropanol indian frankincense chondroitin sulfate (bovine) glucosamine sulfate potassium chloride water ilex paraguariensis leaf magnesium chloride mentha piperita propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-30

Purpose

Analgesic Pain Relief

Description

Camphor 4% Menthol 10%


Medication Information

Purpose

Analgesic Pain Relief

Directions

Adults and children 12 years of age or older: Using the roll-on apllicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information

Store under normal storage conditions. Store away from children.

Inactive Ingredients

Acrylates Copolymer, Aminomethyl Propanol, Boswellia Serrata Resin Extract, Chondroitin Sulfate, D-Glucosamine Sulfate

Potassium, Dimethyl Sulfone (MSM), Eucalyptus Globulus Leaf/Twig Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Magnesium

Chloride, Mentha Piperita (Peppermint) Oil, Propylene Glycol, SD Alcohol 40-B, Water, Zea Mays (Corn) Starch

Description

Camphor 4% Menthol 10%

Uses:

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

Warnings:

For external use only.

  • Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.
Keep Out of Reach of Children.
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away.
Active Ingredietns (% By Weight) Purpose

Camphor 4%

Menthol 10%

Professionl Therapy Musclecare Maximum Strength Pain Relieving Gel Roll On


Structured Label Content

Purpose

Analgesic Pain Relief

Directions

Adults and children 12 years of age or older: Using the roll-on apllicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information

Store under normal storage conditions. Store away from children.

Inactive Ingredients

Acrylates Copolymer, Aminomethyl Propanol, Boswellia Serrata Resin Extract, Chondroitin Sulfate, D-Glucosamine Sulfate

Potassium, Dimethyl Sulfone (MSM), Eucalyptus Globulus Leaf/Twig Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Magnesium

Chloride, Mentha Piperita (Peppermint) Oil, Propylene Glycol, SD Alcohol 40-B, Water, Zea Mays (Corn) Starch

Uses:

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

Warnings:

For external use only.

  • Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away.
Active Ingredietns (% By Weight) Purpose (Active Ingredietns (% by weight) Purpose)

Camphor 4%

Menthol 10%

Professionl Therapy Musclecare Maximum Strength Pain Relieving Gel Roll On (Professionl Therapy MuscleCare Maximum Strength Pain Relieving Gel Roll-on)


Advanced Ingredient Data


Raw Label Data

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