RAYSAIN WASH FREE HAND SANITIZER- hypochlorous acid liquid 
SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD

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.

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Hand sanitizer

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. 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.
  2. 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)

Hypochlorous acid 17% 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

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 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

Other information

Inactive ingredients

purified water

Package Label - Principal Display Panel

0.05L NDC: 52968-001-01

0.05L

0.1L NDC: 52968-001-02

0.1L

0.5L NDC: 52968-001-03

0.5L

1L NDC: 52968-001-04

1L

5L NDC: 52968-001-05

5L

RAYSAIN WASH FREE HAND SANITIZER 
hypochlorous acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52968-001
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID170 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52968-001-010.05 L in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
2NDC:52968-001-020.1 L in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
3NDC:52968-001-030.5 L in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
4NDC:52968-001-041 L in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
5NDC:52968-001-055 L in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/20/2020
Labeler - SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD (529680998)
Establishment
NameAddressID/FEIBusiness Operations
SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD529680998manufacture(52968-001)

Revised: 6/2020
Document Id: a7b1c019-b5a5-ca9d-e053-2a95a90a7724
Set id: a78f5c16-868c-2309-e053-2995a90a16d0
Version: 2
Effective Time: 20200609
 
SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD