Label: DG HEALTH MAXIMUM STRENGTH COLD N HOT- lidocaine hcl, menthol cream
- NDC Code(s): 55910-760-01
- Packager: DOLGENCORP, LLC
- 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 February 7, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use
- on large areas of the body or on cut, irritated, swollen, or blistered skin
- on puncture wounds
- for more than one week without consulting a doctor
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
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Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl stearate SE, phenoxyethanol, purified water, SD alcohol 40, steareth-21
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INGREDIENTS AND APPEARANCE
DG HEALTH MAXIMUM STRENGTH COLD N HOT
lidocaine hcl, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-760 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 40 mg in 1 g LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) C30-45 ALKYL METHICONE (UNII: NFX970DSI2) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 PHOSPHATE (UNII: 921FTA1500) CHLORPHENESIN (UNII: I670DAL4SZ) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) STEARETH-21 (UNII: 53J3F32P58) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-760-01 1 in 1 CARTON 03/30/2020 1 49.6 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/30/2020 Labeler - DOLGENCORP, LLC (068331990)