FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Billion Internet Group SA de CV
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:14:54

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions: Wet hands thoroughly with product, rub, and allow to dry. Children under 6 years of age, use only under adult supervision.

Storage and handling

Do not store above 105°F (43°C). May discolor some fabrics and surfaces.

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) (70%, 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. glycerin
  3. triethanolamine
  4. Carbomer
  5. purified water USP

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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Decrease bacteria on skin

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Stop use and ask a doctor if redness or irritation
develops and persists for more than 72 hours.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes.In
case of contact flush eyes with water.

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 redness or irritation
develops and persists for more than 72 hours.

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

  • Directions: Wet hands thoroughly with product, rub,
    and allow to dry. Children under 6 years of age, use only
    under adult supervision.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105°F (43°C). May discolor some fabrics and surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), CARBOMER, TRIETHANOLAMINE,
GLYCERIN.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5000 mL NDC: 76708-111-05

5000mL Label5000mL Label

4000 mL NDC: 76708-113-04

4000mL Label4000mL Label

20000 mL NDC: 76708-114-20

20000mL Label20000mL Label

250 mL NDC: 76708-112-25

250mL Label250mL Label

8 Oz Hand Sanitizer Label8 Oz Hand Sanitizer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76708-111-052022-01-28C16284748780-1d6a99b39-da97-a426-e053-dadaa90af4c2a3cf0507-8534-c743-e053-2a95a90ae777
76708-112-252022-01-28C16284748780-1d6a99b39-da97-a426-e053-dadaa90af4c2a3cf0507-8534-c743-e053-2a95a90ae777
76708-113-042022-01-28C16284748780-1d6a99b39-da97-a426-e053-dadaa90af4c2a3cf0507-8534-c743-e053-2a95a90ae777
76708-114-202022-01-28C16284748780-1d6a99b39-da97-a426-e053-dadaa90af4c2a3cf0507-8534-c743-e053-2a95a90ae777
76708-222-082022-01-28C16284748780-1d6a99b39-da97-a426-e053-dadaa90af4c2a3cf0507-8534-c743-e053-2a95a90ae777

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76708-111-05Hand Sanitizer5000 mL in 1 JUGGEL50004
76708-112-25Hand Sanitizer250 mL in 1 BOTTLEGEL2504
76708-113-04Hand Sanitizer4000 mL in 1 JUGGEL40004
76708-114-20Hand Sanitizer20000 mL in 1 JUGGEL200004
76708-222-08Hand Sanitizer236 mL in 1 BOTTLEGEL2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76708-111HAND SANITIZER (ALCOHOL) GEL [BILLION INTERNET GROUP SA DE CV]4Legacy NDC, 1 package rows20200528_a3cf0507-8534-c743-e053-2a95a90ae777.zip
76708-112HAND SANITIZER (ALCOHOL) GEL [BILLION INTERNET GROUP SA DE CV]4Legacy NDC, 1 package rows20200528_a3cf0507-8534-c743-e053-2a95a90ae777.zip
76708-113HAND SANITIZER (ALCOHOL) GEL [BILLION INTERNET GROUP SA DE CV]4Legacy NDC, 1 package rows20200528_a3cf0507-8534-c743-e053-2a95a90ae777.zip
76708-114HAND SANITIZER (ALCOHOL) GEL [BILLION INTERNET GROUP SA DE CV]4Legacy NDC, 1 package rows20200528_a3cf0507-8534-c743-e053-2a95a90ae777.zip
76708-222HAND SANITIZER (ALCOHOL) GEL [BILLION INTERNET GROUP SA DE CV]4Legacy NDC, 1 package rows20200528_a3cf0507-8534-c743-e053-2a95a90ae777.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76708-11276708-112-25
76708-11476708-114-20
76708-11176708-111-05
76708-11376708-113-04
76708-22276708-222-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER COPOLYMER TYPE A71DD5V995LIACT

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
a6a5949f-5ec0-f37d-e053-2995a90adae5a3cf0507-8534-c743-e053-2a95a90ae7772020-05-27WarningsExact identifier
spl id: a6a5949f-5ec0-f37d-e053-2995a90adae5
spl set id: a3cf0507-8534-c743-e053-2a95a90ae777

Reported adverse events (FAERS/openFDA)#

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