Label: BABY WIPES WITH ALLANTOIN- allantoin liquid

  • NDC Code(s): 44019-400-80
  • Packager: Yinjing Medical Technology (Shanghai) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 27, 2017

If you are a consumer or patient please visit this version.

  • Baby Wipes with Allantoin
  • ACTIVE INGREDIENT

    Allantoin 0.5%(w/w)

    Skin Protectant

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  • Uses:

    Temporarily protects and helps relieve minor skin irritations

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  • Warnings:

    For external use only.

    When using this product, do not get into eyes.

    Stop use and ask a doctor if the rash persists for more than 7 days,
    or tends to reoccur. Keep out of reach of children

    Stop use and ask a doctor

    if rash persists for more than 7 days, or tends to reoccur.

    Keep out of reach of children.


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  • Directions

    • Open lid, remove tab ans pull wipe through
    •  Take wipe and rub thoroughly over the affected area
    • Use as many wipes as needed
    • DO NOT FLUSH,dispose of used wipes in trash
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  • Inactive Ingredients:

    Water, Propylene Glycol, Polysorbate-20, Chamomilla Recutita Water, Tocopheryl acetate, Benzalkonium chloride, Aloe barbadensis leaf juice, potassium sorbate, Sodium Benzoate, Gluconolactone.

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  • Other Information:

    Store in a cool dry place

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  • Baby Wipes with Allantion 80 Count (44019-400-80)
  • INGREDIENTS AND APPEARANCE
    BABY WIPES WITH ALLANTOIN 
    allantoin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44019-400
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44019-400-80 360 g in 1 BAG; Type 0: Not a Combination Product 08/03/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/03/2016
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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