PAIN RELIEF SIGNATURE CARE- lidocaine hcl 4% cream 
Better Living

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 ingredient                                                         Purpose
Lidocaine HCl 4%..........................................................Topical anesthetic

Uses
For temporary relief of pain associated with pain or itching like minor burns, sunburns, minor cuts, insect bites, skin irritation

Warnings
For external use only.
When using this product • use only as directed • do not bandage tightly • avoid contact with eyes • do not apply to wounds or
damaged skin • do not use in large quantities, particularly over raw surfaces or blistered areas.
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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of
age: consult a doctor.

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl
Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium
EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD Alcohol 40, Steareth-21, Water.

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PAIN RELIEF  SIGNATURE CARE
lidocaine hcl 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-767
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Ceteth-20 Phosphate (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Methylparaben (UNII: A2I8C7HI9T)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-767-031 in 1 CARTON03/15/2018
176.5 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2018
Labeler - Better Living (009137209)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(21130-767) , label(21130-767)

Revised: 1/2018
Document Id: 461f26b4-c4c8-4744-b12b-be38c6c6a5a9
Set id: 88b830da-5a42-48f5-a3b0-17dddef3864a
Version: 1
Effective Time: 20180118
 
Better Living