SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]

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SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]
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NDC 53118-002-01, 53118-002-02
Set ID 48907146-ca66-46e1-928b-a8f968a6bff8
Category HUMAN OTC DRUG LABEL
Packager Precare Corp
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active Ingredient

    Benzalkonium Chloride  0.13%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Do not use if

    you are allergic to any of these ingredients.

    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 children.

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

  • Directions

    adults and children 2 years and over:

    apply to hands; allow to dry without wiping.

    children under 2 years: ask a doctor before use.

    • To dispense: Peel back front label slowly. Remove wipes.
    • To reseal: Firmly rub thumb over label.

    Dispose of wipe in trash. Do not flush.

    For single wipe sachet

    • Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
    • Rub hands together briskly to dry without wiping.
    • Dispose of wipe
    • Do not flush
  • Other Information

    • Store below 95 F (35 C)
    • Keep closed tightly.
    • May discolor certain fabrics or surfaces.

    For single sachet

    store in a cool dry place

  • Inactive ingredients

    Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance

  • Principal Display Panel

    NDC 53118-002-01

    Sanitex®

    Antibacterial

    HAND WIPES

    Kills 99.9% of Germs

    Enriched with Aloe

    FRESH SCENT

    40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

    Label

    NDC 53118-002-02

    Sanitex®

    Antibacterial

    HAND WIPES

    Kills 99.9% of Germs

    Enriched with Aloe

    FRESH SCENT

    20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm)

    Label 1

    NDC 53118-002-03

    Sanitex®

    Antibacterial

    HAND WIPE

    Kills 99.9% of Germs

    Enriched with Aloe

    FRESH SCENT

    1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm)

    Label 2

  • INGREDIENTS AND APPEARANCE
    SANITEX ANTIBACTERIAL HAND WIPES  FRESH SCENT
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53118-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53118-002-0140 in 1 CANISTER06/17/2015
    13 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:53118-002-0220 in 1 BAG06/17/2015
    23 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:53118-002-031 in 1 PACKAGE07/10/2020
    33 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2015
    Labeler - Precare Corp (858442403)
    Registrant - Precare Corp (117111327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precare Corp117111327manufacture(53118-002)
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