ANTISEPTIC HAND SANITIZER

Manufacturer: Pretty Well International Limited | Baicao Shijia Biological Technology (foshan) Co., Ltd
Effective date: 2020-05-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:14:59

Label at a glance#

ProductANTISEPTIC HAND SANITIZER

Active ingredientALCOHOL

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:

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer Purpose

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

in children less than 2 months of age
on open skin wounds Do not use

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. Stop use and ask a doctor if

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. Keep out of reach of children

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. Directions

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP Inactive ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 78348-128-02 Package Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78348-128-02	2021-07-23	C162847	48780-1	c7ccaba7-22e6-fd44-e053-dadaa90aa01b	a69b58af-df17-39f0-e053-2995a90af83d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78348-128-02	ANTISEPTIC HAND SANITIZER	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78348-128	ANTISEPTIC HAND SANITIZER (HAND SANITIZER) SOLUTION [PRETTY WELL INTERNATIONAL LIMITED]	1	Legacy NDC, 1 package rows	20200528_a69b58af-df17-39f0-e053-2995a90af83d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

ANTISEPTIC HAND SANITIZER
Hand Sanitizer
GLYCERIN
HYDROGEN PEROXIDE
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78348-128	78348-128-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML · Source PDF

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a69b58af-df09-39f0-e053-2995a90af83d			a69b58af-df17-39f0-e053-2995a90af83d	2020-05-27	Warnings	Exact identifier spl id: a69b58af-df09-39f0-e053-2995a90af83d spl set id: a69b58af-df17-39f0-e053-2995a90af83d

Reported adverse events (FAERS/openFDA)#

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