Hand Sanitizer

Manufacturer
SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:06

Label at a glance#

ProductRAYSAIN Wash Free Hand Sanitizer
Active ingredientHYPOCHLOROUS ACID
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

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. 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)

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous acid 17% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.05L NDC: 52968-001-01

0.05L0.05L

0.1L NDC: 52968-001-02

0.1L0.1L

0.5L NDC: 52968-001-03

0.5L0.5L

1L NDC: 52968-001-04

1L1L

5L NDC: 52968-001-05

5L5L

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136924957400369GTIN-13: 6924957400369
EAN-13: 6924957400369
GTIN storage (14 digits): 06924957400369
500ml.jpg
BarcodeEAN-136924957400826GTIN-13: 6924957400826
EAN-13: 6924957400826
GTIN storage (14 digits): 06924957400826
1L.jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52968-001-01RAYSAIN Wash Free Hand Sanitizer0.05 L in 1 BOTTLELIQUID0.052
52968-001-02RAYSAIN Wash Free Hand Sanitizer0.1 L in 1 BOTTLELIQUID0.12
52968-001-03RAYSAIN Wash Free Hand Sanitizer0.5 L in 1 BOTTLELIQUID0.52
52968-001-04RAYSAIN Wash Free Hand Sanitizer1 L in 1 BOTTLELIQUID12
52968-001-05RAYSAIN Wash Free Hand Sanitizer5 L in 1 BOTTLELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52968-001RAYSAIN WASH FREE HAND SANITIZER (HYPOCHLOROUS ACID) LIQUID [SHANGHAI RUISHENG BIO-MEDICAL CO.,LTD]2Legacy NDC, 5 package rows20200611_a78f5c16-868c-2309-e053-2995a90a16d0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52968-00152968-001-01, 52968-001-02, 52968-001-03, 52968-001-04, 52968-001-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a7b1c019-b5a5-ca9d-e053-2a95a90a7724a78f5c16-868c-2309-e053-2995a90a16d02020-06-09WarningsExact identifier
spl id: a7b1c019-b5a5-ca9d-e053-2a95a90a7724
spl set id: a78f5c16-868c-2309-e053-2995a90a16d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.