Label: SKIN PROTECTANT- sodium bicarbonate liquid

  • 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 January 18, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Bicarbonate (Baking Soda) 5%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses  temporary relief of itching and irritation due to

    -insect bites and stings   -poison ivy, oak or sumac

  • WARNINGS

    Warnings

    For external use only

    Do not use

    -over large areas of body

    -other than as directed

    When using this product

    -avoid contact with eyes

    Stop use and ask a doctor if

    -symptoms last for more than 7 days

    -the condition becomes worse

    -symptoms clear up and then occur again within a few days


  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children over 2 years of age:

    -apply a small amount directly to the bite, sting or affected area and rub gently

    -re-apply as needed

    children under 2 years of age: ask a doctor before use

  • STORAGE AND HANDLING

    Other information

    store at room temperature 59 - 86F (15 - 30C)

  • INACTIVE INGREDIENT

    Inactive ingredients   ammonia, cyclohexasiloxane,

    cyclopentasiloxane, glycerin, water

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    sodium bicarbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-101-0114 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/18/2016
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(31190-101)
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