Label: LEMON GLYCERIN- glycerin swab

  • NDC Code(s): 34645-2105-3
  • Packager: Jianerkang Medical 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 March 29, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients

    Glycerin USP 50%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Use

    For oral care post operatively and for swabbing whenever special mouth care is prescribed

  • WARNINGS

    Do Not Use

    If pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children

    If swallowed, get medical help or contact Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    Swab mouth as needed. Discard after single use.

  • STORAGE AND HANDLING

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

  • Package Label

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    LEMON GLYCERIN 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-2105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-2105-35 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2010
    Labeler - Jianerkang Medical Co., Ltd (530968767)
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