Label: MOSQUITOES PREVENT- pyrethrum extract 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 December 20, 2022

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  • Active Ingredient(s)

    β-thujaplicin, 5% w/w, Antiseptic

    Pelargonium graveolens,ext., 5% w/w, Antiseptic

    Pyrethrins, 1% w/w, Mosquitoes Prevent

  • Purpose

    β-thujaplicin, Antiseptic

    Pelargonium graveolens,ext., Antiseptic

    Pyrethrins, Mosquitoes Prevent

  • Use

    Anti-mosquito and anti-bacterial for body topical, hair, but not for eyes, and mouth.

  • Warnings

    External use only. Stay away from heat or flames.

    • Do not substitute sterilized medicines for medical procedures.
  • Do not use

    - in babies less than 6 months of age.

  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children

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

  • Directions

    3.5% o.w.f Apply on the desired area.

  • Other information

    Store between 0-40℃ (32-104℉)

  • Inactive ingredients

    Water, Butanediol, Aliphaticpolyurethane

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    MOSQUITOES PREVENT 
    pyrethrum extract liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83141-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.01 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
    WATER (UNII: 059QF0KO0R)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83141-1001-660 kg in 1 DRUM; Type 0: Not a Combination Product12/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G12/21/2022
    Labeler - Jiangsu New Reba Technology Inc. (544096564)
    Registrant - Jiangsu New Reba Technology Inc. (544096564)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu New Reba Technology Inc.544096564manufacture(83141-1001) , label(83141-1001)
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