Label: PRO NUMB- tattoo numbing spray spray

  • NDC Code(s): 83389-111-11
  • Packager: Pro Numb Tattoo Numbing Spray LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 17, 2023

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  • Active Ingredient(s)

    Lidocaine HCI 5% Epinephrine HCI .01%

  • Purpose

    Topical Anesthetic

  • Use

    Temporarily takes away pain, itching, and swelling associated with anorectal disorders or pain-sensitive procedures.

  • Warnings

    External Use Only. Keep out of reach of children.

    Do not use if you have • seizures or liver disease • if pregnant or breastfeeding • a known allergy or sensitivity occurs, discontinue use, and seek medical attention. If the condition intensifies or symptoms persist for more than seven days or clear up and occur again within a few days, Cease the use of this product and consult a doctor. Do not use in large quantities, Particularly over raw surfaces or blistered areas. Avoid contact with the eyes. If contact should occur, irrigate with large amounts of sterile saline and seek medical attention. Do not swallow, if swallowed, seek medical attention immediately.

    When using this product, you may notice temporary whiting or redness of the skin where pro numb is applied.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Sensitivity test encouraged before use. Spray a small amount on the broken area of the skin. Wait 60 seconds for the anesthetic to start working. Wash Pro Numb off completely before tattooing.

  • Other information

    Store in a cool dark place or refrigerate and keep out of reach of children. Discard the item after the expiration date is due.

  • Inactive ingredients

    purified RO water, Paraben-DU, Disodium EDTA, Citric acid, Optiphen.

  • QUESTIONS

    Call: (800) 865-4965

  • Package Label - Principal Display Panel

    ProNumb Spray120mL Spray NDC: 83389-111-11

  • INGREDIENTS AND APPEARANCE
    PRO NUMB 
    tattoo numbing spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83389-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE0.1 mg  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83389-111-11120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/12/2023
    Labeler - Pro Numb Tattoo Numbing Spray LLC (118964052)
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