Label: ALLURE ICE COLD ANALGESIC- menthol and camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52000-004-13, 52000-004-14, 52000-004-15, 52000-004-16, view more52000-004-17, 52000-004-18 - Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
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 July 27, 2012
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding,
- Keep out of the reach of children
- Directions
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLURE ICE COLD ANALGESIC
menthol and camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER 934 (UNII: Z135WT9208) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-004-17 127 g in 1 TUBE 2 NDC:52000-004-18 170 g in 1 TUBE 3 NDC:52000-004-13 170 g in 1 BOTTLE, PLASTIC 4 NDC:52000-004-14 226 g in 1 BOTTLE, PLASTIC 5 NDC:52000-004-15 300 g in 1 BOTTLE, PLASTIC 6 NDC:52000-004-16 500 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2012 Labeler - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-004)