Label: ASSURED BUG BITE RELIEF- 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 June 30, 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

    Do not use

    • over large areas of the body
    • other than as directed
  • WHEN USING

    When using this product

    • avoid contact with eyes
  • STOP USE

    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 of 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 - 86 F (15 - 30 C)

  • INACTIVE INGREDIENT

    Inactive ingredients   ammonia, cyclohexasiloxane,

    cyclopentasiloxane, glycerin, water

  • DESCRIPTION

    Assured's Bug Bite Relief helps to relieve a wide range

    of irritation and itching associated with the most common

    and annoying insect bites. When you feel the sting, reach

    for the soothing relief of Assured's Bug Bite Relief.

    Easy. Convenient. Effective.

    Always keep it with you. On - the - go or at home.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ASSURED  BUG BITE RELIEF
    sodium bicarbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-039-0114 g in 1 APPLICATOR; Type 0: Not a Combination Product11/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/10/2015
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-039)
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