Label: DISINFECTANTSPRAY- hydrogen peroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 6, 2021

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

  • Active Ingredients

    Hydrogen Peroxide 5%

  • Purpose

    Antimicrobial

  • Uses

    Disinfectant spray to help reduce bacteria that potentially can cause diesease.

  • Warnings

    For external use only

  • Warnings

    in childer less than 2 months of age

    on open skin wounds

  • Warnings

    When using this product keep out of eyes, ears, and moyth, In case of contact with eyes, rinse eyes thoroughly with water.

  • Warnings

    Stop use and ask a doctor if irritation or rash occurs.

    These may be signs of a serious condition.

  • Warnings

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Other Information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Directions

    It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Hold container 6"-8' from surface and spray until thoroughly wet then allow to air dry. For difficult odors, repeat application. For leather, rayon, acrylic, silk, rayon acetate or satin fabrics, always test on a hidden area of fabric before using.

  • Inactive Ingredients

    Water, Glycine, Zinc Chloride, Manganese (II) Chloride Tetrahydrate, Calcium Chloride Dihydrate, Copper (II) Chloride Dihydrate, Imidazole, EDTA2Na Dihydrate

  • Package Label

    60ml NDC: 81057-301-01

    500ml NDC: 81057-301-02

  • INGREDIENTS AND APPEARANCE
    DISINFECTANTSPRAY 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81057-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    IMIDAZOLE (UNII: 7GBN705NH1)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    MANGANESE CHLORIDE (UNII: QQE170PANO)  
    EDETIC ACID DIHYDRATE (UNII: Q48G4KK684)  
    WATER (UNII: 059QF0KO0R)  
    GLYCINE (UNII: TE7660XO1C)  
    CUPRIC CHLORIDE (UNII: S2QG84156O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81057-301-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/23/2020
    2NDC:81057-301-02500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/23/2020
    Labeler - NOVAWEAR INC. (109383529)
    Registrant - YSA TRADING CO., LTD (695146678)
    Establishment
    NameAddressID/FEIBusiness Operations
    YSA TRADING CO., LTD695146678manufacture(81057-301)