Label: TOPICOOL PAIN RELIEF WITH CATS CLAW- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57698-100-04 - Packager: TENSproducts, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 1, 2018
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- Active Ingredients:
- Purpose:
- Uses:
- Warnings:
- Directions:
- Other information:
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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
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- PRINCIPAL DISPLAY PANEL - 113.4 g Tube Label
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INGREDIENTS AND APPEARANCE
TOPICOOL PAIN RELIEF WITH CATS CLAW
menthol gelProduct 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)