Label: NOBLIPS JB-100 SANITIZER- hypochlorous acid liquid

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 9, 2020

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

  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Hypochloric Acid 5% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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.

  • STOP USE

    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

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    CHAMAECYPARIS Obtusa Leaf, Lonicera Japonica Leaf/stem, Lonicera Japonica Flower, Jingko Leaf Extract, Citrus Unshiu Peel, Purified Water

  • Package Label - Principal Display Panel

    500ml NDC: 79592-0010-1500 mL NDC: 79592-0010-1

  • INGREDIENTS AND APPEARANCE
    NOBLIPS JB-100 SANITIZER 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79592-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GINKGO (UNII: 19FUJ2C58T) 1 mL  in 100 mL
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) 1 mL  in 100 mL
    LONICERA JAPONICA TOP (UNII: 60Q6UP226V) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 92 mL  in 100 mL
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) 1 mL  in 100 mL
    TANGERINE (UNII: KH3E3096OO) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79592-0010-1500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/09/2020
    Labeler - JooBio (695838761)
    Registrant - JooBio (695838761)
    Establishment
    NameAddressID/FEIBusiness Operations
    JooBio695838761manufacture(79592-0010)