Label: HOT ICE SOOTHING ANALGESIC GEL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 34954-013-07 - Packager: Kim Chemicals LTD
- 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 September 20, 2009
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- Active Ingredients
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- Uses
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Warnings
For external use only. Not for internal use.
Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.
Do not use with heating pads or heating devices.
It 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. If you have sensitive skin, 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 spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.
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INGREDIENTS AND APPEARANCE
HOT ICE SOOTHING ANALGESIC GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34954-013 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 WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) CAMPHOR (UNII: 5TJD82A1ET) CARBOMER 934 (UNII: Z135WT9208) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34954-013-07 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/21/2009 Labeler - Kim Chemicals LTD (650470164)