Label: RAYSAIN WASH FREE HAND SANITIZER- hypochlorous acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52968-001-01, 52968-001-02, 52968-001-03, 52968-001-04, view more52968-001-05 - Packager: SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD
- 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 June 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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:
- Hypochlorous acid (17%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- 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
RAYSAIN WASH FREE HAND SANITIZER
hypochlorous acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52968-001 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 170 mg in 1 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52968-001-01 0.05 L in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 2 NDC:52968-001-02 0.1 L in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 3 NDC:52968-001-03 0.5 L in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 4 NDC:52968-001-04 1 L in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 5 NDC:52968-001-05 5 L in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/20/2020 Labeler - SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD (529680998) Establishment Name Address ID/FEI Business Operations SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD 529680998 manufacture(52968-001)