PAIN RELIEF- lidocaine hcl cream 
Topco

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 Analgesic

Uses

Uses For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation

Warnings

​For external use only

When using this product • avoid contact with eyes • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of the children.

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

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 Extract, 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 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-740
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)  
ALCOHOL (UNII: 3K9958V90M)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-740-0377 g in 1 CONTAINER; Type 0: Not a Combination Product11/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/17/2017
Labeler - Topco (006935977)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(36800-740) , label(36800-740)

Revised: 7/2018
Document Id: 38ede9ed-60d3-4baf-9d81-7eb5266084cb
Set id: 58cb1b71-2343-4283-bd5f-4ece0cc92ae2
Version: 1
Effective Time: 20180725
 
Topco