MUSCLECARE PROFESSIONAL THERAPY PAIN RELIEVING- menthol and camphor ointment

MuscleCare by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient (% by weight)

Camphor 4.0%
Menthol 4.0%

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.

• 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 within a few 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
  

Directions:

Adults and children 12 years of age or older: Rub this soothing cream 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:

Water/Aqua; Cetyl Alcohol, Glycol Stearate, MSM (Methylsulfonylmethane), Glycerin, Stearyl Alcohol, Glucosamine Sulfate, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Tocopheryl (Vitamain E) Acetate, Oil of Wintergreen (Methyl Salicylate), Cucumaria (Sea Cucumber) Frondosa, Grape Seed Oil, Urea, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Polysorbate-20, Eucalyptus Globulus Leaf Oil, Thymol, Aloe Barbadensis Leaf Juice, Chondroitin Sulfate, Magnesium Chloride

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MUSCLECARE  PROFESSIONAL THERAPY PAIN RELIEVING
menthol and camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.6 g  in 115 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.6 g  in 115 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCOL STEARATE (UNII: 0324G66D0E)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ACRYLAMIDE (UNII: 20R035KLCI)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CUCUMARIA FRONDOSA (UNII: 4M1271AZ6G)
GRAPE SEED OIL (UNII: 930MLC8XGG)
UREA (UNII: 8W8T17847W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
THYMOL (UNII: 3J50XA376E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULFATE ION (UNII: 7IS9N8KPMG)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-027-08	115 g in 1 TUBE

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 Progess (961956229)

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