Label: ICY HOT WITH LIDOCAINE NO-MESS- menthol and lidocaine liquid
- NDC Code(s): 41167-1715-1, 41167-1715-3
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
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Purposes
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Menthol 1%.......................................................................................................................................Topical analgesic
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Warnings
For external use only
Flammable
■ keep away from heat and open flame
Do not use
■ on puncture wounds, cuts, irritated or swollen skin
■ in large quantities, particularly over raw surfaces or blistered areas
■ with a heating pad or a medicated patch to the area of use
When using this product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ avoid applying into skin folds
■ rare cases of serious burns have been reported with products of this type
■ a transient burning sensation may occur upon application but generally disappears in several days
Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ severe burning sensation, redness or irritation develop
■ experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
- Directions
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICY HOT WITH LIDOCAINE NO-MESS
menthol and lidocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-1715 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-1715-1 70.8 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 2 NDC:41167-1715-3 42.5 g in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/01/2018 Labeler - Chattem, Inc. (003336013)
