Label: INSTACLEAN HAND SANITIZING- alcohol gel

  • 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 January 13, 2022

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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. Children should be supervised by an adult when using this product.

  • Uses

    • To decrease bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • Warnings

    • Flammable, keep away from heat or flame
    • For external use only
  • Other Information

    Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

    May discolor certain fabrics and surfaces.

  • Stop use and ask a doctor

    if irritation and redness develop or if condition persists more than 72 hours.

  • Directions

    • Apply sufficient amount of product to your palm to cover both hands.
    • Rub until dry.
  • Inactive Ingredients

    Aloe Bardensis juice, Alpha Tocopherol, Carbopol 2020, FD&C Blue No.1, FD&C Yellow No. 5, Fragrance, PEG-18 Dimethicone, TEA, Water

  • PRINCIPAL DISPLAY PANEL

    drug fcat panel

  • INGREDIENTS AND APPEARANCE
    INSTACLEAN  HAND SANITIZING
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-8046-2118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2018
    2NDC:52410-8046-3532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2018
    3NDC:52410-8046-4800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2018
    4NDC:52410-8046-51000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2015
    Labeler - SHIELD LINE LLC (078518916)
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