Label: COLD THERAPY- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68678-013-90 - 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 April 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- Uses
- Active Ingredient
- Purpose
- Directions
- Warnings
- When using this product:
- Stop use and ask doctor if:
- Keep Out of Reach of Children
- Other Information:
- Inactive Ingredients:
- If Pregnant or Breast Feeding:
- PDP
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INGREDIENTS AND APPEARANCE
COLD THERAPY
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68678-013 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 EUCALYPTUS OIL (UNII: 2R04ONI662) 0.05 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 5 mL in 100 mL ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 1 mL in 100 mL DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 0.03 mL in 100 mL PEPPERMINT OIL (UNII: AV092KU4JH) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) 32.906 mL in 100 mL ALCOHOL (UNII: 3K9958V90M) 48.45 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL in 100 mL (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) 0.004 mL 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:68678-013-90 95 mL in 1 BOTTLE, DISPENSING; 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) Establishment Name Address ID/FEI Business Operations Vege Labs LLC. 117878620 manufacture(68678-013)
