Label: BLACKWORK- numbing spray spray

  • NDC Code(s): 77632-123-60
  • Packager: Private Label Productions LLC
  • 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 5, 2023

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  • Active Ingredient(s)

    Lidocaine HCI 5%

  • Purpose

    Topical Anesthetic

  • Use

    For temporary relief of pain, soreness or burning.

  • Warnings

    ■ For external use only. Do not use this product with a mechanical device. ■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. ■ Do not exceed the daily recommended dosage. ■ In case of any bleeding, discontinue use and consult a doctor. ■ Keep this and all drugs out of reach of children. In case of accidential overdose, seek medical help or call a Poison Control Center right away. ■ As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

  • Directions

    ■ Cleanse affected area with mild soap and water. Gently dry by palling or blotting with tissue or a soft cloth before application. ■ Apply externally to the affected area up to 6 times daily.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Other information

    Store at 20-25°C ( equals 68-77°F)

  • Inactive ingredients

    Purified Water, Ethoxydiglycol, Benoy Alcohol, Phenoxyethanol, Allantoin, Disodium EDTA

  • Package Label - Principal Display Panel

    NumbingSpray-6060 mL: NDC: 77632-123-60

  • INGREDIENTS AND APPEARANCE
    BLACKWORK 
    numbing spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77632-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77632-123-6060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/31/2023
    Labeler - Private Label Productions LLC (046278265)
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