Label: RECOVERY NUMBING- lidocaine hcl spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCl 5 %

  • PURPOSE

    Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    USES: Temporarily relieves pain, itching and burning associated with inflamed hemorrhoidal tissues.

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY

  • STOP USE

    Stop and ask a doctor if an allergic reaction or rectal bleeding occurs; redness, irritation, swelling, pain or other symptoms begin or increase; condition worsens or does not improve within 7 days.

  • 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. If pregnant or breast-feeding, ask a health professional before use.

    If pregnant or breast-feeding, ask a health professional before use.

  • DIRECTIONS:

    Adults and children 12 years and older: When practical, clean area with mild soap and warm water and rinse thoroughly. Gently pat or blot dry with a clean tissue or soft cloth before applying. Apply to the affected area up to 6 times a day.

    Children under 12 years of age: Consult a doctor.

  • OTHER SAFETY INFORMATION

    Other information: Store between 14C - 25C (58F - 77F). Avoid freezing, excessive heat or direct sunlight.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

  • STATEMENT OF IDENTITY

    RECOVERY

    NUMBING SPRAY

    FAST-ACTING TOPICAL

    ANESTHETIC WITH ALOE

    NET WT 4 FL OZ (118 mL)

    NDC 76348-585-04

  • WHEN USING

    When using this product avoid contact with eyes

    Rinse with water to remove

    Do not use in large quantities particularl over raw skin or blistered areas

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL

    product label

  • INGREDIENTS AND APPEARANCE
    RECOVERY NUMBING 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-980
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5.9 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-980-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01508/01/2022
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-980)
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