Xianyou Hand Sanitizer Alcohol Wipes

Manufacturer
Zhengzhou Xianyou Pharmaceutical Technology Co., Ltd.
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:25

Label at a glance#

ProductXianyou Hand Sanitizer Alcohol Wipes
Active ingredientISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Take a piece of this product, 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 Alcohol wipes 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. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Benzalkonium Chloride (0.1% v/v).
  3. 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

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Benzalkonium Chloride 0.1% v/v. Purpose:Fungicide

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. Not Recommended for repeated use.

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

  • Take a piece of this product, 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

40 pcs NDC: 79001-001-40 40 Pcs Wipes40 Pcs Wipes

50 pcs NDC: 79001-001-50 50 Pcs wipes50 Pcs wipes80 pcs NDC: 79001-001-80 80 Pcs Wipes80 Pcs Wipes120 pcs NDC: 79001-001-12 120pcs wipes120pcs wipes 40 pcs NDC: 79001-001-41 40 pcs/Box wipes40 pcs/Box wipes

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79001-001-12Xianyou Hand Sanitizer Alcohol Wipes120 mL in 1 POUCHCLOTH1201
79001-001-40Xianyou Hand Sanitizer Alcohol Wipes40 mL in 1 POUCHCLOTH401
79001-001-41Xianyou Hand Sanitizer Alcohol Wipes40 mL in 1 POUCHCLOTH401
79001-001-50Xianyou Hand Sanitizer Alcohol Wipes50 mL in 1 POUCHCLOTH501
79001-001-80Xianyou Hand Sanitizer Alcohol Wipes80 mL in 1 POUCHCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79001-001XIANYOU HAND SANITIZER ALCOHOL WIPES (ISOPROPYL ALCOHOL) CLOTH [ZHENGZHOU XIANYOU PHARMACEUTICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 5 package rows20200812_a9717348-87bd-3812-e053-2995a90aa63a.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79001-00179001-001-40, 79001-001-50, 79001-001-80, 79001-001-12, 79001-001-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
a970626b-5dd3-41be-e053-2a95a90a8099a9717348-87bd-3812-e053-2995a90aa63a2020-07-02WarningsExact identifier
spl id: a970626b-5dd3-41be-e053-2a95a90a8099
spl set id: a9717348-87bd-3812-e053-2995a90aa63a

Reported adverse events (FAERS/openFDA)#

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