PROFESSIONAL THERAPY MUSCLECARE EXTRA STRENGTH- menthol, camphor gel

Professional Therapy MuscleCare by

Drug Labeling and Warnings

Professional Therapy MuscleCare by is a Otc medication manufactured, distributed, or labeled by Active and Innovative Inc., Delta Pharma Inc., PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

For Muscle and Joint Pain Relief

ACTIVE INGREDIENTS (% BY WEIGHT) PURPOSE

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

Menthol 10.0%...................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 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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other Information: Store under normal storage conditions. Store away from children.

INACTIVE INGREDIENT

Inactive Ingredients: Peppermint leaf oil (Mentha piperita), Eucalyptus globus leaf oil, Dimethyl sulfone (MSM), Boswellia Carterii Extract, Ilex Paraguariensis (Mate) leaf extract, Glucosamine sulfate, Chondroitin sulfte, Magnesium chloride, Tocopherol (natural Vitamin E), Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Water, Ethanol, Glycerin, UREA, Hydroxypropyl methylcellulose.

Professional Therapy MuscleCare Extra Strength Pain Relieving Gel by Dr. Chris Oswald

INGREDIENTS AND APPEARANCE

PROFESSIONAL THERAPY MUSCLECARE  EXTRA STRENGTH
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70039-200
Route of Administration	CUTANEOUS, TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
TOCOPHEROL (UNII: R0ZB2556P8)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
UREA (UNII: 8W8T17847W)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70039-200-02	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2017

Labeler - Active and Innovative Inc. (206978079)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(70039-200)