Label: AMAR ICE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 41499-123-01 - Packager: AMAR REMEDIES LIMITED
- 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 April 14, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 227 g Jar Label
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INGREDIENTS AND APPEARANCE
AMAR ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41499-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) 0.7 g in 100 g MethylParaben Sodium (UNII: CR6K9C2NHK) PropylParaben Sodium (UNII: 625NNB0G9N) Methyl Salicylate (UNII: LAV5U5022Y) Propylene Glycol (UNII: 6DC9Q167V3) Phenoxyethanol (UNII: HIE492ZZ3T) Propyl Alcohol (UNII: 96F264O9SV) 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:41499-123-01 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2010 Labeler - AMAR REMEDIES LIMITED (677141751)