Label: PINE ANTIBACTERIAL WET WIPES- pine essential oil liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 7, 2020

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

  • Active Ingredient

    PINUS DENSIFLORA WHOLE(Pine Essential Oil) 0.4%

  • Purpose

    Antimicrobial

  • Inactive Ingredients

    WATER(Purified Water), LAMINARIA JAPONICA(Kelp Extract), CHAMAECYPARIS OBTUSA WHOLE(Chamaecyparis Obtusa Extract)

  • Use

    Peel front label slowly
    Pull out wipes as needed

  • Use

    Re-seal label after each use to prevent moisture loss

  • Caution

    If any irritation develops, stop using and consult a doctor if necessary.

  • Caution

    Do not use on damaged skin and avoid using on open scars.

  • Caution

    Keep out of reach of children.

  • Caution

    Keep in dry cool place, avoiding direct sunlight.

    Be careful when handling the packaging edges as they are sharp.

  • Caution

    There is a risk of deterioration if you put the wipes back inside with contaminated hands.

  • Caution

    Be sure to keep the sticker or cap closed after use.

  • Package Label

    95g NDC: 77200-002-20 Label 1

    95g NDC: 77200-002-20 Label 2

    95g NDC: 77200-002-20 Label 3

    360g NDC: 77200-002-80 Label 1

    360g NDC: 77200-002-80 Label 2

    360g NDC: 77200-002-80 Label 3

  • INGREDIENTS AND APPEARANCE
    PINE ANTIBACTERIAL WET WIPES 
    pine essential oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77200-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PINUS DENSIFLORA WHOLE (UNII: U797H98B8Y) (PINUS DENSIFLORA WHOLE - UNII:U797H98B8Y) PINUS DENSIFLORA WHOLE0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAECYPARIS OBTUSA WHOLE (UNII: 80ZNL1G5XY)  
    WATER (UNII: 059QF0KO0R)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77200-002-2095 g in 1 POUCH; Type 0: Not a Combination Product05/04/2020
    2NDC:77200-002-80360 g in 1 POUCH; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/04/2020
    Labeler - SY Global Inc (695625425)
    Registrant - SY Global Inc (695625425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jungwon Company694119406manufacture(77200-002)