Label: PAIN RELIEF WELL AT WALGREENS- lidocaine hcl 4% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 19, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient                                               Purpose

    Lidocaine HCl 4%                                              Topical Anesthetic

  • PURPOSE

  • Uses

    temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises

  • 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 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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  WELL AT WALGREENS
    lidocaine hcl 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3178
    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:0363-3178-061 in 1 CARTON07/30/2015
    176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-3178-031 in 1 CARTON07/30/2015
    271 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/30/2015
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(0363-3178) , label(0363-3178)