Label: BABY WIPES cloth

  • Contains inactivated NDC Code(s)
    NDC Code(s):     54016-005-01, 54016-005-02, 54016-005-03, 54016-005-04, view more
    54016-005-05, 54016-005-06, 54016-005-07, 54016-005-08, 54016-005-09, 54016-005-10, 54016-005-11, 54016-005-12, 54016-005-13, 54016-005-14
  • Packager: Jinhua Huihuang Non-woven Products Co., Ltd.
  • 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 24, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride

  • Purpose

    Antiseptic

  • Use

    For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

  • Warnings

    • For external use only.
    • Highly Flammable - Keep away from fire or flame.
  • Do not use

    • On open skin wounds.
  • WHEN USING

    • Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
    • Avoid contact with broken skin. Do not inhale or ingest.
  • STOP USE

    Stop use and ask a doctor if skin irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

  • Directions

    • Wipe hands, discard properly in trash receptacle.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store at room temperature. Do not store above 105℉.
    • Do not freeze
    • May discolor some fabrics. Harmful to wood finishes and plastics.
    • Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.
  • Inactive ingredients

    2-Bromo-2-nitro-1,3-propanediol, Chitosan, Polysorbate 20, Propylene Glycol, Citric Acid, Purified Water.

  • Package Label - Principal Display Panel

    NDC:54016-005-01 60PCS 54016-005-01

    NDC:54016-005-02 1PCS 54016-005-02

    NDC:54016-005-03 10PCS

    54016-005-03

    NDC:54016-005-04 15PCS

    54016-005-04NDC:54016-005-05 20PCS

    20NDC:54016-005-06 25PCS

    25NDC:54016-005-07 30PCS

    30NDC:54016-005-08 40PCS

    40NDC:54016-005-09 50PCS

    50NDC:54016-005-10 80PCS

    80NDC:54016-005-11 90PCS

    90NDC:54016-005-12 100PCS

    100NDC:54016-005-13 120PCS

    120NDC:54016-005-14 150PCS

    150

  • INGREDIENTS AND APPEARANCE
    BABY WIPES 
    baby wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54016-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.03 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54016-005-0160 in 1 PACKET09/09/2020
    16.85 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:54016-005-021 in 1 PACKET09/09/2020
    26.85 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:54016-005-0310 in 1 PACKET09/09/2020
    36.85 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:54016-005-0415 in 1 PACKET09/09/2020
    46.85 mL in 1 PATCH; Type 0: Not a Combination Product
    5NDC:54016-005-0520 in 1 PACKET09/09/2020
    56.85 mL in 1 PATCH; Type 0: Not a Combination Product
    6NDC:54016-005-0625 in 1 PACKET09/09/2020
    66.85 mL in 1 PATCH; Type 0: Not a Combination Product
    7NDC:54016-005-0730 in 1 PACKET09/09/2020
    76.85 mL in 1 PATCH; Type 0: Not a Combination Product
    8NDC:54016-005-0840 in 1 PACKET09/09/2020
    86.85 mL in 1 PATCH; Type 0: Not a Combination Product
    9NDC:54016-005-0950 in 1 PACKET09/09/2020
    96.85 mL in 1 PATCH; Type 0: Not a Combination Product
    10NDC:54016-005-1080 in 1 PACKET09/09/2020
    106.85 mL in 1 PATCH; Type 0: Not a Combination Product
    11NDC:54016-005-1190 in 1 PACKET09/09/2020
    116.85 mL in 1 PATCH; Type 0: Not a Combination Product
    12NDC:54016-005-12100 in 1 PACKET09/09/2020
    126.85 mL in 1 PATCH; Type 0: Not a Combination Product
    13NDC:54016-005-13120 in 1 PACKET09/09/2020
    136.85 mL in 1 PATCH; Type 0: Not a Combination Product
    14NDC:54016-005-14150 in 1 PACKET09/09/2020
    146.85 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/09/2020
    Labeler - Jinhua Huihuang Non-woven Products Co., Ltd. (540165729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinhua Huihuang Non-woven Products Co., Ltd.540165729manufacture(54016-005)
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