Label: AVEDANA COOL HOT ICE- menthol gel
- NDC Code(s): 43749-321-08
- Packager: Unipack, Inc.
- 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 1, 2018
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- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- When using this product
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other information
- Other ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
AVEDANA COOL HOT ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-321 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-321-08 227 g in 1 JAR; Type 0: Not a Combination Product 11/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/04/2017 Labeler - Unipack, Inc. (009248480) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(43749-321)