MUSCLECARE PROFESSIONAL THERAPY PAIN RELIEVING- camphor and menthol gel

MuscleCare by

Drug Labeling and Warnings

MuscleCare by is a Otc medication manufactured, distributed, or labeled by Active and Innovative, Creations Garden Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (% by weight)

Camphor 4.0%

Menthol 10.0%

Purpose

Analgesic (Pain Relief)

Analgesic (Pain Relief)

Uses:

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

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 or clear up and occur again with in a few days, discontinue use of this products 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.
  

Directions:

Adults and children 12 years of age or older. Using the roll-on applicator, message a liberal amount of gel directly on the affected area not more than 3 to 4 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:

Alcohol Denat, Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Propylene Glycol, Glycerin, MSM (Methylsulfonymethane), Boswellia Serrata Extract,  Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine

Questions?

416-967-3746

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MUSCLECARE  PROFESSIONAL THERAPY PAIN RELIEVING
camphor and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.5 g  in 85 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.4 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
SULFATE ION (UNII: 7IS9N8KPMG)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-026-07	85 g in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/21/2011

Labeler - Active and Innovative (961956229)

Registrant - Creations Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products		961956229	manufacture