Drug Facts

Active ingredient	Purpose
Menthol 12%	Pain Relieving
Camphor 6%	Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

simple backache
arthritis
strains
sprains

Warnings

For external use only.

do not apply to wounds or damaged skin
do not bandage tightly
do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

avoid contact with other mucous membranes

Extremely Flammable: Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control center right away
if pregnant or nursing, seek the advice of a health professional before using

Directions

Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
Children under 12 years of age consult a physician
Apply a thin layer to affected area not more than 3 to 4 times daily
Gently massage into the skin until fully absorbed
Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol (Phenagon PDI), DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call 1-888-373-8831 or visit us at www.conceptlabs.org

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

TRIPLE
POWER
PAIN RELIEF

SUPER COOLING
FAST ACTING

MENTHOL & CAMPHOR

+
ARNICA,
ROSEMARY
& ACAI

NET WT 3.75 OZ (106 g)

Principal Display Panel - 106 g Bottle Label

TRIPLE POWER PAIN RELIEF
menthol, unspecified form and camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64058-341
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.12 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
STARCH, CORN (UNII: O8232NY3SJ)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LINSEED OIL (UNII: 84XB4DV00W)
ROSEMARY OIL (UNII: 8LGU7VM393)
ACAI OIL (UNII: Z0W6766A2W)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
LAURYL LAURATE (UNII: GPW77G0937)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64058-341-64	106 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	06/25/2015

Labeler - Concept Laboratories, Inc. (962282612)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-341)