Label: ICY HOT WITH LIDOCAINE NO-MESS- menthol and lidocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-3788-9 - Packager: Rite Aid Hdgrts Corp
- 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 November 20, 2022
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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
- Use
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Warnings
For external use only
Do not use
■ on large areas of the body or on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
When using this product
■ use only as directed. Read and follow all directions and warnings on this carton.
■ 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
■ avoid applying into skin folds
- Directions
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Inactive ingredients
2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol
- 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:11822-3788 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 CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYL ALCOHOL (UNII: ND2M416302) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-3788-9 70.8 g in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/30/2020 Labeler - Rite Aid Hdgrts Corp (014578892) Registrant - Velocity Pharma LLC (962198409)