Label: BABY WIPES- propylene glycol cloth

  • NDC Code(s): 79539-401-01, 79539-401-02, 79539-401-03, 79539-401-04, view more
    79539-401-05, 79539-401-06, 79539-401-07, 79539-401-08, 79539-401-09, 79539-401-10
  • Packager: Shandong Yayun Sanitary Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Baby Wipes

  • Active Ingredient(s)

  • Purpose

    Antiseptic, Baby Wipes

  • Use

    Baby Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • on open skin wounds
  • 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

    • Wipe the surface of the skin and let it dry naturally
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    WATER
    Aloe Barbadensis Leaf Extract
    Chamomile Extract
    Phenoxyethanol
    DMDM Hydantoin
    Ethylhexylglycerin
    Benzalkonium Chloride

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    BABY WIPES 
    propylene glycol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79539-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79539-401-011 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:79539-401-0210 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:79539-401-0320 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:79539-401-0430 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:79539-401-0540 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    6NDC:79539-401-0650 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    7NDC:79539-401-0760 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    8NDC:79539-401-0870 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    9NDC:79539-401-0980 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    10NDC:79539-401-10100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/30/2020
    Labeler - Shandong Yayun Sanitary Products Co., Ltd. (419983491)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Yayun Sanitary Products Co., Ltd.419983491manufacture(79539-401)
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