THERACARE 4% LIDOCAINE CREAM- lidocaine hydrochloride cream 
Veridian Healthcare

----------

TheraCare 4% Lidocaine Cream

Active ingredient

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only. Avoid contact with eyes.

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.
  • do not allow contact with the eyes and mucus membranes
  • do not bandage or apply local heat (such as heating pads) 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

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 (800-222-1222) right away.

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water

PRINCIPAL DISPLAY PANEL
TheraCare 4% Lidocaine Cream

label

THERACARE 4% LIDOCAINE CREAM 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-930
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-21 (UNII: 53J3F32P58)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-930-011 in 1 CARTON07/01/2021
149.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71101-930)

Revised: 5/2024
Document Id: 18fab885-9bd2-3f68-e063-6294a90a8a86
Set id: c808aa05-9d49-cc9f-e053-2a95a90a50f3
Version: 3
Effective Time: 20240521
 
Veridian Healthcare