Label: ARCTIC ICE ANALGESIC GEL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51328-2050-1 - Packager: ROYAL EXPORTS
- 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 September 4, 2018
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings
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Do not use with heating pads or heating devices
If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARCTIC ICE ANALGESIC GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51328-2050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.27 g in 227 g Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 934 (UNII: Z135WT9208) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51328-2050-1 227 g in 1 JAR; Type 0: Not a Combination Product 09/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/21/2018 Labeler - ROYAL EXPORTS (650621381)