FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Big Bang Services, L.L.C
Effective date
2020-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:16

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

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

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).

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (73%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.5% w/w).

3. Hydroxypropylcellulose(Kulcel H) (1.1% w/w).

4. Ceraphyl 31 ester (1.0% w/w)

a. Lauryl Alcohol

b. Myristyl Alcohol

c. Cetyl Alcohol
5. Denatonium benzoate
6. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 73% w/w. 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 Poison Control Center right away.

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.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

purified water USP, hydroxypropyl cellulose, glycerin, myristyl lactate,
cetyl lactate, lauryl lactate, denatonium benzoate(bitterant/denaturant)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 ml NDC:75184-003-01 5 mL Label5 mL Label

59 ml NDC:75184-003-02 59 ml Label59 ml Label 59 ml front59 ml front

118 ml NDC:75184-003-04 118 ml Label118 ml Label 118 ml Label118 ml Label

237 ml NDC:75184-003-08 237 ml Label237 ml Label 237 ml Label237 ml Label

3785 ml NDC:75184-003-10 3785 ml Label3785 ml Label 3785 ml Label3785 ml Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75184-003-012022-01-28C16284748780-1d6a99b39-a6cb-a426-e053-dadaa90af4c2a56bd182-9482-080e-e053-2995a90aecc2
75184-003-022022-01-28C16284748780-1d6a99b39-a6cb-a426-e053-dadaa90af4c2a56bd182-9482-080e-e053-2995a90aecc2
75184-003-042022-01-28C16284748780-1d6a99b39-a6cb-a426-e053-dadaa90af4c2a56bd182-9482-080e-e053-2995a90aecc2
75184-003-082022-01-28C16284748780-1d6a99b39-a6cb-a426-e053-dadaa90af4c2a56bd182-9482-080e-e053-2995a90aecc2
75184-003-102022-01-28C16284748780-1d6a99b39-a6cb-a426-e053-dadaa90af4c2a56bd182-9482-080e-e053-2995a90aecc2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75184-003-01Hand Sanitizer5 mL in 1 BOTTLE, SPRAYSOLUTION51
75184-003-02Hand Sanitizer59 mL in 1 BOTTLE, DISPENSINGSOLUTION591
75184-003-04Hand Sanitizer118 mL in 1 BOTTLE, DISPENSINGSOLUTION1181
75184-003-08Hand Sanitizer237 mL in 1 BOTTLE, DISPENSINGSOLUTION2371
75184-003-10Hand Sanitizer3785 mL in 1 BOTTLESOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75184-003HAND SANITIZER (ALCOHOL) SOLUTION [BIG BANG SERVICES, L.L.C]1Legacy NDC, 5 package rows20200514_a56bd182-9482-080e-e053-2995a90aecc2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75184-00375184-003-01, 75184-003-02, 75184-003-08, 75184-003-10, 75184-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CETYL LACTATEA7EVH2RK4OIACT
MYRISTYL LACTATE1D822OC34XIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)UKE75GEA7FIACT
LAURYL LACTATEG5SU0BFK7OIACT
WATER059QF0KO0RIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

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
a56bd182-9483-080e-e053-2995a90aecc2a56bd182-9482-080e-e053-2995a90aecc22020-05-11WarningsExact identifier
spl id: a56bd182-9483-080e-e053-2995a90aecc2
spl set id: a56bd182-9482-080e-e053-2995a90aecc2

Reported adverse events (FAERS/openFDA)#

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