Label: NOBLIPS JB-100 SANITIZER- hypochlorous acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79592-0010-1 - Packager: JooBio
- 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
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- Official Label (Printer Friendly)
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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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
NOBLIPS JB-100 SANITIZER
hypochlorous acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79592-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 3 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79592-0010-1 500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/09/2020 Labeler - JooBio (695838761) Registrant - JooBio (695838761) Establishment Name Address ID/FEI Business Operations JooBio 695838761 manufacture(79592-0010)