Label: NUMB SKIN- lidocaine and benzethonium chloride 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 November 9, 2022

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  • Active Ingredient

    Lidocaine 4%

    benzethonium Chloride 0.25%

  • Purpose

    External Analgesic and First Aid Antiseptic

  • Uses

    • Can be used instead of soap and water to help clean minor cuts, scrapes, and burns
    • For the temporary relief of discomfort and pain associated with dermal procedures such as tattoo removal, dermarolling, electrolysis, microblading, and piercing
    • Temporarily relieves pain and itch while helping to prevent infection.
  • Warnings

    • For external use only
    • avoid contact with eyes ​​

    Do not use

    • do not use in large quantities particularly over raw surfaces or blistered area
    • do not exceed the recommended dosage unless directed by a doctor
    • in the eyes or apply over large areas of body
    • longer than one week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    Stop the use and consult doctor if:

    • condition worsenss or symptoms persist for more than 7 days or clear up and occur again within few days.

    Keep out of reach of children

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

  • Directions

    • Use NumbSkin® Topical Anesthetic Foam Soap to cleanse the targeted area.
    • Shake well before each use.
    • Apply 2 to 3 pumps of foam soap andgently rub into the skin. Leave it onfor 5 to 10 minutes. Rinse off gentlywith running water or wipe with cleanpaper towel.
    • Use before, during andafter the procedure.
    • Make sure tocover the bottle tightly when not inuse, otherwise, the anesthetic effect will be lessened.

    Adults and children two years old and older: Use to clean minor cuts, scrapes, and burns by thoroughly washing with water. Rinse and air dry. Use no more than three times daily.

    Children under two years of age, ask a doctor.

  • Other information

    • Store at controlled room temperature 59 0​-86 0​F (15 0-30 0C)
    • Do not expose to temperature above 120 0F(49 0C)
    • Protect from freezing
  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Benzyl Alcohol, Glycerin , Lauramidopropyl Betaine, Leuconostoc/Radish Root Ferment Filtrate, Menthoxypropanediol, Phenoxyethanol, Selaginella Lepidophylla Extract, Sodium Hydroxide, Water.

  • Question or comments?

    Call weekdays 9 AM to 6 PM PST at 1-844-700- NUMB(6862) or email us at support@numbskin.com

  • Principal Display Panel

    NDC 70907-002-50

    NUMBSKIN

    TOPICAL ANESTHETIC FOAM SOAP

    4% LIDOCAINE

    0.25% BENZETHONIUM CHLORIDE

    DISINFECT NUMB SANITIZE

    1.7 oz

    Label

  • INGREDIENTS AND APPEARANCE
    NUMB SKIN  
    lidocaine and benzethonium chloride cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70907-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 50 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.25 mg  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SELAGINELLA LEPIDOPHYLLA (UNII: 02JQ564P1G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70907-002-501 in 1 CARTRIDGE09/11/2017
    150 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 finalpart34809/11/2017
    Labeler - Seenext Venture Ltd (203416862)
    Registrant - Seenext Venture Ltd (203416862)
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