TOPICOOL PAIN RELIEF WITH CATS CLAW- menthol gel

TopiCool Pain Relief by

Drug Labeling and Warnings

TopiCool Pain Relief by is a Otc medication manufactured, distributed, or labeled by TENSproducts, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Camphor 0.4%

Menthol 4.5%

Purpose:

External Analgesic

External Analgesic

Uses:

For the temporary relief of

• arthritis
• backache
• sprains
• strains

Warnings:

Use only as directed.
For external use only.

Do not use

• with other topical products
• on open wounds or damaged skin

Ask a doctor or pharmacist if you are

pregnant or breastfeeding

Stop use and consult a doctor if

symptoms persist for more than 7 days

Avoid contact with eyes
Do not bandage tightly
Keep away from excessive heat or open flame

KEEP OUT OF REACH OF CHILDREN.

In case of ingestion, seek professional assistance and contact poison control immediately.

Directions:

• Adults and children 2 years of age and older apply to affected area not more than 4 times daily
• rub in thoroughly until gel is absorbed

Other information:

Store at room temperature with cap closed.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Boswellia Serrata Extract, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tetrasodium EDTA, Triethanolamine, Uncaria Tomentosa (Cat's Claw) Extract, Zemea Propanediol

Questions or Comments?

(866) 449-1010 or www.tensproducts.com

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Label

TopiCool™
Pain relief gel with Cat's Claw

NET WT 4 OZ (113.4g)

INGREDIENTS AND APPEARANCE

TOPICOOL PAIN RELIEF  WITH CATS CLAW
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57698-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4.5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)
CAT'S CLAW (UNII: 9060PRM18Q)
TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57698-100-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2013

Labeler - TENSproducts, Inc. (121251883)