LIDOCAINE PAIN RELIEVING CREME- lidocaine hydrochloride cream 
Velocity Pharma LLC

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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Lidocaine Pain Relieving Creme- CareOne

Lidocaine Pain Relieving Creme

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

Uses

temporarily relieves minor pain 

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.
  • do not allow contact with the eyes
  • 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 and pets.

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

Directions

adults and children over 12 years:

children 12 years and younger: ask a doctor

Inactive ingredients

butylated hydroxy toluene, cetomacrogol 1000, cetostearyl alcohol, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate anhydrous, light liquid paraffin, propylene glycol,­purified water, sorbic acid, transcutol P, white petroleum jelly.

Keep Carton As It Contains Important Information

Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

1

LIDOCAINE PAIN RELIEVING CREME 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-206
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CETETH-20 (UNII: I835H2IHHX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBIC ACID (UNII: X045WJ989B)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-206-331 in 1 CARTON09/30/2020
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2020
Labeler - Velocity Pharma LLC (962198409)

Revised: 9/2020
Document Id: b0901b6b-3c79-7aa7-e053-2a95a90a626b
Set id: b090075a-9556-7a81-e053-2a95a90af2e0
Version: 1
Effective Time: 20200930
 
Velocity Pharma LLC