Label: NUMBED AS FXXK- topical anesthetic cream 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 July 9, 2023

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  • Active Ingredient(s)

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Use

    For the temporary relief of pain

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Not for prolonged use.

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away +1 800-222-1222

  • STOP USE

    Stop Use and Ask a Doctor if the condition worsens ■ symptoms persist for more than seven days or clear up and occur again within a few days. Rash or irritation develops, persists, or increases. If pregnant or breastfeeding, ask a health professional before use.

  • Directions

    Adults and children 2 years old and older Clean the affected area Apply to affected area not more than 3 to 4 times daily Remove residue if desired Children under 2 years old: Consult 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclopentasiloxane, Denatonium Benzoate,Dicetyl Phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Gyceryl Stearate, lsohexadecane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Maltodextrin, Phenoxyethanol, Simmondsia Chinensis(Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Water.

  • QUESTIONS

    Call (754) 248 - 2548

  • Package Label - Principal Display Panel

    Label 57mL2 OZ Cream, NDC: 83371-112-11

  • INGREDIENTS AND APPEARANCE
    NUMBED AS FXXK 
    topical anesthetic cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83371-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-21 (UNII: 53J3F32P58)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALCOHOL 95% (UNII: 7528N5H79B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83371-112-1157 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2023
    Labeler - Blackbull Store LLC (085247371)
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