Label: INSIGNIA ENGLAND DISINFECTANT- alcohol 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 June 8, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use

    Disinfectant Spray to help reduce germs that potentially can cause disease

  • 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

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

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • 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 hands and wipe hands together to ensure even coverage
    • Allow to dry naturally
    • Spray onto the surface of object and after one minute, wipe down with a cloth
    • When used in appliances, spray onto cloth first before wiping
  • Other information

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

    Water, Glycerin, Hydrogen peroxide, Fragrance (Citrus lemon)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INSIGNIA ENGLAND DISINFECTANT 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75410-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CITRUS LIMON WHOLE (UNII: EEI224A33Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75410-004-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    2NDC:75410-004-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    3NDC:75410-004-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    4NDC:75410-004-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    5NDC:75410-004-05550 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    6NDC:75410-004-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    7NDC:75410-004-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - Yiwu Story of Love Cosmetic Co., Ltd (679768544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Story of Love Cosmetic Co., Ltd679768544manufacture(75410-004)
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