Label: REDICLEANSE INSTANT HAND SANITIZER- instant hand sanitizer 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 July 2, 2021

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  • ACCESSORIES

    Redicleanse Instant Hand Sanitizer is formulated to sanitize hands in sitsuations where water is unavailable. Kills 99.9% of most common organisms in 15 seconds or less without using water.

  • Active ingredient

    Ethyl Alcohol 62% v/v

  • Purpose

    Antibacterial Agent

  • Uses

    • For hand cleaning to decrease bacteria on skin
  • Warnings

    For external use only.

    ___________________________________

    Flammable. Keep away from heat or flame.

    Do not use in the eyes.

    In case of contact, rinse thoroughly.

    Keep out of reach of children.

    If swallowed, contact a physician or poison center.

    Stop and ask a doctor

    if irriation and redness appears and lasts.

  • Directions

    • To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.
    • Children should be supervised when using this product.

    To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Isoproyl Myristate, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl Propanol.

  • STATEMENT OF IDENTITY

    Manufactured for

    redicare

    Redicare LLC / Congers, NY 10920

    866.561.5650

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    redicleanse

    Instant Hand Sanitizer

    Kills 99.9% of common germs

    Net Contents: 237mL (8 Fl. Oz.)

  • INGREDIENTS AND APPEARANCE
    REDICLEANSE INSTANT HAND SANITIZER 
    instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.25 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.001 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 35.468 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.18 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.25 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 100 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.35 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-056-01237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2016
    Labeler - Redicare LLC (800149346)
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