PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL EXTRA STRENGTH- camphor, menthol gel

Professional Therapy MuscleCare pain relieving gel by

Drug Labeling and Warnings

Professional Therapy MuscleCare pain relieving gel by is a Otc medication manufactured, distributed, or labeled by Active and Innovative Inc., PureTek Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (% by weight) Purpose

Camphor 4.0%................................Analgesic (pain relief)

Menthol 10.0%.................................Analgesic (pain relief)

Uses:

For 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 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: Using the roll-on applicator 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:

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

PURPOSE

FOR MUSCLE & JOINT PAIN RELIEF

PRINCIPAL DISPLAY PANEL

Extra Strength Pain Relieving Gel

by Dr. Chris Oswald

Net Wt

3oz. (85g)

INGREDIENTS AND APPEARANCE

PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL  EXTRA STRENGTH
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70039-283
Route of Administration	CUTANEOUS, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70039-283-07	1 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2015

Labeler - Active and Innovative Inc. (206978079)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corp.		785961046	manufacture(70039-283)