Label: COLD SPOT POINT RELIEF- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51452-005-04 - Packager: Fabrication Enterprises, inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 13, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
aqua (deionized water), arnica montana flower (arnica) extract, boswella serrata extract, brtomelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, menth piperita (pepperment) oil, methyl paraben, MSM (dimethyl sulfone) polysorbate-80, SD-alcohol 40B, triethanolamine
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD SPOT POINT RELIEF
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.4 mL in 120 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 4.8 mL in 120 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) BROMELAINS (UNII: U182GP2CF3) CARBOMER 1342 (UNII: 809Y72KV36) Eucalyptus Globulus leaf (UNII: S546YLW6E6) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) Peppermint Oil (UNII: AV092KU4JH) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) alcohol (UNII: 3K9958V90M) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-005-04 4 mL in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/13/2011 Labeler - Fabrication Enterprises, inc. (070577218) Registrant - Pure Source (969241041) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture