Label: DISINFECTANT SPRAY(SPEEDY EFFECT TYPE)- alcohol, chlorhexidine acetate liquid

  • 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 April 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Disinfectant Spray(Speedy effect type)

  • Active Ingredient(s)

    Alcohol 63% v/v.

    Chlorhexidine acetate 0.5g/100mL

    Purpose: Antiseptic

  • Purpose

    Antiseptic, Disinfectant Spray(Speedy effect type)

  • Use

    Disinfect the surface of objects

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Spray on the surface of the object to disinfect
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    1,2-Propanediol
    Medicinal Glycerin
    Primary Alcobol Ethoxylate
    Purity Water

  • Package Label - Principal Display Panel

    500 mL NDC: 74974-011-01

    LABEL

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT SPRAY(SPEEDY EFFECT TYPE) 
    alcohol, chlorhexidine acetate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74974-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.5 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 PARETH-10 (UNII: Z0QJT9586T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74974-011-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Swashes (Shenzhen) Co., Ltd. (421263450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swashes (Shenzhen) Co., Ltd.421263450manufacture(74974-011)
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