PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING- menthol, camphor ointment

Professional Therapy MuscleCare Pain Relieving by

Drug Labeling and Warnings

Professional Therapy MuscleCare Pain Relieving 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

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

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

USE:

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 you are 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: Rub this soothing cream onto the effected 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:Dimethyl sulfone (MSM), Gluosamine sulfate, Tocopherol (natural Vitamin E), Safflower Oleosomes (Carthamus Tinctorius), Wintergreen leaf oil (Gaultheria fragrantissima Wall), Eucalyptus leaf oil 9Eucalyptus globus), Grape seed oil (Vitis vinifera), Aloe babadensis leaf juice, Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Chondroitin sulfate, Cetyl alcohol, Cetearyl alcohol & Polysorbate-20, Glycerin, Acacia Senegal Gum & Xanthan Gum, Urea, Phenoxyethanol & ethylhexyl glycerin, Water, Magnesium chloride.

Professional Therapy MuscleCare Pain Relieving Ointment by Dr. Chris Oswald

INGREDIENTS AND APPEARANCE

PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING 
menthol, camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70039-300
Route of Administration	CUTANEOUS, TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
METHYL SALICYLATE (UNII: LAV5U5022Y)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
THYMOL (UNII: 3J50XA376E)
XANTHAN GUM (UNII: TTV12P4NEE)
UREA (UNII: 8W8T17847W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACACIA (UNII: 5C5403N26O)
TOCOPHEROL (UNII: R0ZB2556P8)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70039-300-02	115 g in 1 TUBE; 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(70039-300)