MENTHOLATUM LIDOCAINE HEAT- lidocaine hcl cream 
The Mentholatum Company

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.

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Drug Facts

Active ingredients

Lidocaine HCl 4%

Purpose

Lidocaine HCl - Topical anesthetic

Uses

temporarily relieves pain

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or blistered skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed
  • do not get into eyes
  • do not bandage tightly or apply external heat to the area of use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, rash, or irritation occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, 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 monostearate, phenoxyethanol, polysorbate 20, purified water, steareth-21, vanillyl butyl ether

Package/Label Principal Display Panel

Mentholatum Lidocaine Heat
MENTHOLATUM LIDOCAINE HEAT 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8386
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
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 MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
STEARETH-21 (UNII: 53J3F32P58)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8386-11 in 1 CARTON08/01/2018
180 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2018
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8386)

Revised: 2/2023
Document Id: f41f301d-d454-0cac-e053-2995a90ab741
Set id: cc2ef25a-b569-4d48-a666-899f710b4b34
Version: 4
Effective Time: 20230207
 
The Mentholatum Company