Label: PROTECT 8- benzalkonium chloride 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 July 30, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    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, or if condition persists for more than 72 hours.

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam onto hands.

    Rub thoroughly over all surfaces of both hands.

    Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    PROTECT 8

    Hand

    Sanitizer

    Alcohol Free

    Fragrance Free

    Gentle on Skin

    16.9 FL OZ (500mL)

    container label2 container label2

  • INGREDIENTS AND APPEARANCE
    PROTECT 8 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    C12-15 PARETH-7 (UNII: 3XY03A79QH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63002-003-339.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/15/2017
    2NDC:63002-003-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
    3NDC:63002-003-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
    4NDC:63002-003-95950 mL in 1 BAG; Type 0: Not a Combination Product01/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2017
    Labeler - Advanced Hygienics LLC (065359009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(63002-003)
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