Label: COLD SPOT POINT RELIEF- menthol aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 51452-003-16 - 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
- INACTIVE INGREDIENT
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- WARNINGS
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
COLD SPOT POINT RELIEF
menthol aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 48 mL in 480 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) Citric Acid (UNII: 2968PHW8QP) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) Glucosamine sulfate (UNII: 1FW7WLR731) Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F) Isopropyl Alcohol (UNII: ND2M416302) Peppermint Oil (UNII: AV092KU4JH) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) polysorbate 20 (UNII: 7T1F30V5YH) alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-003-16 480 mL in 1 BOTTLE, SPRAY 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