Label: ICY HOT POWER- menthol gel
- NDC Code(s): 41167-0086-0
- Packager: Chattem, Inc.
- 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 1, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
■ use only as directed. Read and follow all directions and warnings on this label.
■ avoid contact with eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ do not apply to wounds or damaged, broken or irritated skin
■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ do not expose the area treated with product to heat or direct sunlight
■ avoid applying into skin folds
- Directions
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Inactive ingredients
alcohol denat. (15%), allantoin, aloe barbadensis leaf juice, carbomer, diisopropyl adipate, eucalyptus globulus leaf oil, glycerin, mentha piperita (peppermint) oil, methyl salicylate, steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water
Dist. by Chattem, Inc., P.O. Box 2219Chattanooga, TN 37409-0219, U.S.A ©2009
www.icyhot.com
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INGREDIENTS AND APPEARANCE
ICY HOT POWER
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0086 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.16 g in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) METHYL SALICYLATE (UNII: LAV5U5022Y) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) THYME OIL (UNII: 2UK410MY6B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0086-0 49 g in 1 CONTAINER; Type 0: Not a Combination Product 12/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/01/2009 Labeler - Chattem, Inc. (003336013) Establishment Name Address ID/FEI Business Operations CHATTEM, INC. 003336013 ANALYSIS(41167-0086) , LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086) Establishment Name Address ID/FEI Business Operations CHATTEM, INC. 830410721 LABEL(41167-0086) , MANUFACTURE(41167-0086) , PACK(41167-0086)