Label: COLD THERAPY- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 68678-012-04, 68678-012-16, 68678-012-32 - Packager: AHC Ventures Corp DBA Cryoderm
- 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 May 9, 2022
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- Stop use and ask doctor if:
- Inactive Ingredients
- If Pregnant or Breast Feeding
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- Active Ingredient
- Uses
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- Keep Out Of Reach Of Children
- INSTRUCTIONS FOR USE
- Inactive Ingredients
- PDP
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INGREDIENTS AND APPEARANCE
COLD THERAPY
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68678-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) 1 mL in 100 mL BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) 1 mL in 100 mL EUCALYPTOL (UNII: RV6J6604TK) 0.05 mL in 100 mL ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 1 mL in 100 mL DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 2 mL in 100 mL PEPPERMINT OIL (UNII: AV092KU4JH) 0.05 in 100 mL WATER (UNII: 059QF0KO0R) 33.5 in 100 mL ALCOHOL (UNII: 3K9958V90M) 51.4 mg in 100 mL Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68678-012-32 1008 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2016 2 NDC:68678-012-16 504 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2016 3 NDC:68678-012-04 126 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2016 Labeler - AHC Ventures Corp DBA Cryoderm (131871779)
