Label: BUFFERIN LIDOCAINE PAIN NUMBING- lidocaine hydrochloride 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 August 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 4%

  • Purpose

    Topical analgesics

  • Use

    For the temporarily relief of pain

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas
    • on wounds or damaged skin

    When using this product

    • use only as directed
    • avoid contact with eyes
    • do not apply tight bandages
    • do not apply a heating pad to treated skin

    Stop use and ask a doctor If

    • condition worsens or symptoms persist for more than 7 days
    • symptoms 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 to avoid accidental ingestion

  • SPL UNCLASSIFIED SECTION

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • use only as directed

    Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daiIy

    Chidren under 12 years of age: ask a doctor

  • Other information

    • store at 15 to 30"C (59 to 86"F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    Purified water, Aloe barbadensis leaf juice, Cetyl alcohol, Ethoxydiglycol, Stearic acid, Hemp seed oil, Sodium polyacrylate, Jojoba oil, Jeecide cap-5 (Phenoxyethanol, Caprylyl glycol, Potassium sorbate, Hexylene glycol), L-arginine, Benzophenone-4

  • Questions or comments?

    Call toll free 1-877-994-3666

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    GENOMMA LAB USA, INC.,
    HOUSTON, TX 77098

  • PRINCIPAL DISPLAY PANEL - 76.5 g Tube Carton

    irwin
    naturals®

    BUFFERIN®

    +
    1000 mg
    Hemp Seed Oil*
    PER TUBE
    CURATED FROM IRWIN NATURALS®

    LIDOCAINE 4%
    PAIN NUMBING CREAM

    MAX STRENGTH†

    BLOCKS PAIN RECEPTORS
    HOURS OF RELIEF
    *FOR SKIN CONDITIONING

    NUMBS PAIN FAST
    †WITHOUT A PRESCRIPTION

    NET. WT 2.7 OZ (76.5 g)

    PRINCIPAL DISPLAY PANEL - 76.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BUFFERIN LIDOCAINE PAIN NUMBING 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-614
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Cetyl alcohol (UNII: 936JST6JCN)  
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    jojoba oil (UNII: 724GKU717M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-614-271 in 1 CARTON08/18/2023
    176.5 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 FINALpart34808/18/2023
    Labeler - Genomma Lab USA (832323534)
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