LIDOCAINE PAIN RELIEVING CREME- lidocaine hydrochloride cream 
Yash Pharmaceuticals

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.

Outer Label

ODOR FREE
WITH 4% LIDOCAINE 
Pain Relieving Crème
Net wt 2.7 oz (76.5 g)

192 bottles in a case.

Scan0036

LIDOCAINE PAIN RELIEVING CREME 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71301-006
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-2 (UNII: 7H8VAM7778)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
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:71301-006-24192 in 1 CASE03/17/2017
176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2017
Labeler - Yash Pharmaceuticals (871409551)
Registrant - VELOCITY PHARMA (962198409)
Establishment
NameAddressID/FEIBusiness Operations
Yash Pharmaceuticals871409551manufacture(71301-006) , label(71301-006)

Revised: 9/2017
Document Id: 5929523a-a740-d20b-e053-2a91aa0a395f
Set id: 48984478-b215-4e37-b37c-47de96263083
Version: 2
Effective Time: 20170914
 
Yash Pharmaceuticals