Label: SIGNATURE CARE BITE AND STING RELIEF- benzocaine spray

  • 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 March 11, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzocaine 5%

  • PURPOSE

    Purpose

    External analgesic

  • INDICATIONS & USAGE

    Uses For the Temporary Relief of pain and itching associated with insect bites

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

  • STOP USE

    Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    shake well, adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract

    Ascorbic Acid

    Camphor

    Chamomilla Recutita (Matricaria) Flower Extract

    Cholecalciferol

    Diisopropyl Adipate

    Eugenia Caryophyllus (Clove) Flower Oil

    Fragrance

    Mentha Piperita (Peppermint) Oil

    Octyldodecanol

    Olea Europaea (Olive) Fruit Oil

    PEG-8 Dimethicone

    Propylene Glycol

    Pyridoxine HCl

    Retinyl Palmitate

    SD Alcohol 40

    Silica

    Sodium Propoxyhydroxypropyl Thiosulfate Silica

    Tocopheryl Acetate

    Zea Mays (Corn) Oil

  • PRINCIPAL DISPLAY PANEL

    Signature Care Bite & Sting Relief Spray

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE BITE AND STING RELIEF 
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CORN OIL (UNII: 8470G57WFM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-143-0185 g in 1 CAN; Type 0: Not a Combination Product03/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/11/2020
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(21130-143)
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