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 hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly

Keep Carton As It Contains Important Information

Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

ODOR FREE
WITH 4% LIDOCAINE
MAXIMUM STRENGTH
Pain Relieving Crème
Care one

Careone Lidocaine 4.7oz

LIDOCAINE PAIN RELIEVING CREME 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-201
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CETETH-2 (UNII: 7H8VAM7778)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBIC ACID (UNII: X045WJ989B)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-201-321 in 1 CARTON09/14/2017
1130 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 finalpart34809/14/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)
Establishment
NameAddressID/FEIBusiness Operations
Yash Pharmaceuticals871409551manufacture(76168-201)

Revised: 9/2017
Document Id: 5928833c-a1bb-58bd-e053-2a91aa0a4c59
Set id: 924d84a8-f4f1-46b8-a661-1f6a4e322df6
Version: 2
Effective Time: 20170914
 
Velocity Pharma LLC