Label: ALCOSM ANTIBACTERIAL WIPES- benzalkonium chloride cloth

  • 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 14, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antiseptic

  • USE

    ●For hand sanitizing to decrease bacteria on the skin.
    ●Apply topically to the skin to help prevent cross contamination.
    ●Not recommended for repeated use.
    ●Dries in seconds.

  • Warning

    For external use only. Flammable, keep away from fire or flame.
    When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush thoroughly with water.
    Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

  • Directions

    Remove lid. Pull wipe from center of roll and thread through opening in lid. Do not push finger through
    opening. Replace lid, pull wipe up and then out at 45° angle. Next wipe dispenses automatically. Close lid to retain moisture.

  • Inactive ingredients

    Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben, Methylparaben, Polysorbate 20, Fragrance, Disodium
    EDTA, Sodium Citrate, Cetylpyridinium Chloride.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ALCOSM ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-507
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75109-507-01600 in 1 CARTON07/05/2020
    11 in 1 PACKAGE
    15.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:75109-507-02100 in 1 CARTON07/05/2020
    210 in 1 PACKAGE
    258 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:75109-507-0324 in 1 CARTON07/05/2020
    350 in 1 PACKAGE
    3270 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:75109-507-0416 in 1 CARTON07/05/2020
    480 in 1 PACKAGE
    4430 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:75109-507-0516 in 1 CARTON07/05/2020
    5100 in 1 PACKAGE
    5530 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    6NDC:75109-507-0612 in 1 CARTON07/05/2020
    675 in 1 CANISTER
    6420 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    7NDC:75109-507-0712 in 1 CARTON07/05/2020
    7150 in 1 CANISTER
    7420 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    8NDC:75109-507-0812 in 1 CARTON07/05/2020
    8240 in 1 CANISTER
    8760 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    9NDC:75109-507-092 in 1 CARTON07/05/2020
    9350 in 1 CANISTER
    92768 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/05/2020
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-507)
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