FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Boss (Huizhou) Medical & Health Products Co., Ltd. | Hans Manufacturer, Inc.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:05

Label at a glance#

ProductHand 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:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (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

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer and disinfectant spray 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 USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 77313-875-11

30ml label front30ml label front

30ml label back230ml label back2

30ml label back130ml label back1

60 mL NDC: 77313-875-12

60ml label front60ml label front

60ml label back160ml label back1

60ml label back260ml label back2

100 mL NDC: 77313-875-13

100ml label front100ml label front

100ml label back1100ml label back1

100ml label back2100ml label back2

150 mL NDC: 77313-875-14

150ml label front150ml label front

150ml label back1150ml label back1

150ml label back2150ml label back2

250 mL NDC: 77313-875-15

250ml label front250ml label front

250ml label back1250ml label back1

250ml label back2250ml label back2

400 mL NDC: 77313-875-16

400ml label front400ml label front

400ml label back400ml label back

500 mL NDC: 77313-875-17

500ml label front500ml label front

500ml label back500ml label back

750 mL NDC: 77313-875-18

750ml label front750ml label front

750ml label back750ml label back

750 mL round bottle NDC: 77313-875-19

750ml round bottle front750ml round bottle front

750ml round bottle label back1750ml round bottle label back1

750ml round bottle label back2750ml round bottle label back2

1000 mL NDC: 77313-875-20

1000ml label front1000ml label front

1000ml label back1000ml label back

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77313-87577313-875-11, 77313-875-12, 77313-875-13, 77313-875-14, 77313-875-15, 77313-875-16, 77313-875-17, 77313-875-18, 77313-875-19, 77313-875-20

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
ALCOHOL3K9958V90MACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1f10bf0-ec06-3da0-e053-2995a90a1b40a5b7044f-48b6-6203-e053-2995a90acae02023-01-10WarningsExact identifier
spl id: f1f10bf0-ec06-3da0-e053-2995a90a1b40
spl set id: a5b7044f-48b6-6203-e053-2995a90acae0

Reported adverse events (FAERS/openFDA)#

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