Label: REDDOT HAND SANITIZER- hand sanitizer 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 December 16, 2021

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  • Directions

    • Receive appropriate amount of sanitizer to palm of hand.
    • Rub thoroughly over all surfaces of both hands.
    • Continue to rub hands together until dry.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Eye irritant. In case of contact, immediately flush eyes for 15 minutes. If irritation persists, get medical attention. Harmful if swallowed.

  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% . . . . . . . . . Antimicrobial

  • Use

    Recommended for repeated use

    Purpose

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only.

  • WHEN USING

    When using this product:

    • Avoid contact with eyes. In case of eye contact, flush eyes with water
    • Stop use and ask a doctor if irritation or redness develops, and if condition persists for more than 72 hours.
  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact poison control right away

  • Directions

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry
  • Inactive ingredients

    Water, cocoamidopropyl PG-dimonium chloride phosphate, dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid

  • Questions

    Contact RedDot Brands Mon-Fri 9am-5pm EST at 608-524-4341

  • Package Label - Principal Display Panel

    REORDER: DC7000

    Manufactured for:

    Hankscraft, Inc./ dba RedDot Brands

    300 Wengel Drive

    Reedsburg, WI 53959

    608-524-4341

    www.reddotbrands.com

    Foaming Non-Alcohol Hand Sanitizer

    with Benzalkonium Chloride

    Alcohol-Free

    Foaming

    Hand Sanitizer

    reddot

    Net Contents: 1000 mL NDC: 80821-028-01

    Label

  • INGREDIENTS AND APPEARANCE
    REDDOT HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80821-028(NDC:78245-200)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 1 mL  in 1 mL
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 1 mL  in 1 mL
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR) 1 mL  in 1 mL
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) 1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80821-028-011000 mL in 1 BAG; Type 0: Not a Combination Product10/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - A J S & Associates, Inc (184763118)
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