Label: SANITIZING WIPES- wipes swab

  • 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 September 16, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.13 %

  • Purpose

    Antiseptic

  • Use

    For sanitizing and to help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in or near the eyes.
    • on open skin wounds or burns
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a 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 Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Apply to hands and skin. No rinsing required. Discard after use.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Avoid freezing and store below 110F (43C).
    • Dispose the used wipe in trash, do not flush it into the toilet.
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    cetylpyridinium chloride, chlorphenesin, propylene glycol, glycerol, water, ethylhexylglycerin

  • Package Label - Principal Display Panel

    800 PCS NDC: 71745-124-01

    800 PCS NDC:52489-421-01

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52489-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52489-421-01800 in 1 BAG09/16/2020
    1800 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:52489-421-02800 in 1 CANISTER09/16/2020
    2800 mL 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 finalpart333A09/16/2020
    Labeler - Imperial Palace Commodity (Shenzhen) Co., Ltd (527796368)
    Establishment
    NameAddressID/FEIBusiness Operations
    Imperial Palace Commodity (Dongguan) Co., Ltd544367643manufacture(52489-421)
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