Label: REDICARE BLOOD CLOTTING- blood clotting spray aerosol, 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 September 26, 2023

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  • Active Ingredients

    Benzethonium Chloride 0.2% w/w

    Lidocaine 4% w/w

  • Purpose

    Topical Antiseptic

    Topical Antiseptic

  • Uses

    • for help in the control of superficial bleeding
    • for temporary relief of pain and to help protect against skin infection in minor cuts, minor scrapes, and minor burns

  • WARNINGS

    For external use only.

    Flammable

    • Keep away from flame. Contents under pressure.
    • Do not puncture or incinerate.
    • Do not expose to temperatures above 120°(F)

    DO NOT USE

    • in eyes or other mucous membranes
    • on large portions of the body
    • in case of deep or puncture wounds
    • on raw surfaces
    • on blistered areas
    • on animal bites
    • on serious burns

    DO NOT USE

    • in eyes or other mucous membranes
    • on large portions of the body
    • in case of deep or puncture wounds
    • on raw surfaces
    • on blistered areas
    • on animal bites
    • on serious burns

    Stop use and ask doctor if:

    • Redness, swelling, or irritation occurs
    • Infection occurs
    • The condition persists or worsens
    • Symptoms persist for more than 7 days

    Stop use and ask doctor if:

    • Redness, swelling, or irritation occurs
    • Infection occurs
    • The condition persists or worsens
    • Symptoms persist for more than 7 days

    Keep out of reach of children.

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

  • Directions

    • shake well before using
    • hold 6-8 inches from moist injured area
    • spray until the area is covered
    • Scab-like cover will gradually disappear as healing takes place or may be removed with soap and water
    • for adult institutional use only
    • not intended for use on children
  • Inactive Ingredients

    Isobutane, Isopropyl Myristate, Karaya, N-Butane, Propane, Silica, Silicone, Sorbitan Monooleate, Talc, Tragacanth

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • INGREDIENTS AND APPEARANCE
    REDICARE BLOOD CLOTTING 
    blood clotting spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3400 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANE (UNII: T75W9911L6)  
    3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TALC (UNII: 7SEV7J4R1U)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    KARAYA GUM (UNII: 73W9IQY50Q)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRAGACANTH (UNII: 2944357O2O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-107-0385 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2023
    Labeler - Redicare LLC (800149346)
    Registrant - Redicare LLC (800149346)
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