Label: LUCKY BLUE ICE- menthol camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 47046-167-01 - Packager: Anicare Pharmaceuticals Pvt. Ltd.
- 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 December 20, 2020
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- Active ingredients
- Purpose
- Use
- Warnings
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
LUCKY BLUE ICE
menthol camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47046-167 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 ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER 934 (UNII: Z135WT9208) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47046-167-01 227 g in 1 JAR; Type 0: Not a Combination Product 11/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/2009 Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)