Label: COLD SPOT POINT RELIEF- menthol, methyl salicylate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51452-001-16 - Packager: Fabrication Enterprises
- 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 5, 2010
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
COLD SPOT POINT RELIEF
menthol, methyl salicylate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 58 mL in 480 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 19 mL in 480 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8) CARBOMER 1342 (UNII: 809Y72KV36) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Eucalyptus Globulus LEAF (UNII: S546YLW6E6) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Ilex Paraguariensis LeaF (UNII: 1Q953B4O4F) PROPYLPARABEN (UNII: Z8IX2SC1OH) Peppermint Oil (UNII: AV092KU4JH) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) polysorbate 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-001-16 480 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/24/2010 Labeler - Fabrication Enterprises (070577218) Registrant - Fabrication Enterprises (070577218) Establishment Name Address ID/FEI Business Operations Fabrication Enterprises 070577218 relabel Establishment Name Address ID/FEI Business Operations pure source 969241041 manufacture