FDA.reportPublic FDA data

Generic -Hand Sanitizer

Manufacturer
Generic Specialties, Inc. | Generic Secialties, Inc.
Effective date
2020-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:45

Label at a glance#

ProductGeneric -Hand Sanitizer
Active ingredientALCOHOL
Label structure15 sections

Indications and uses

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

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. As referenced on the product labels.

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) (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.
Triethanolamine
Vitamin E
Aloevera extract
Acrylate crosspolymer
Fragrance
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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, anti-microbial, Hand Sanitizer

See details in the labels attached below....

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

when using this product

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

OTC - STOP USE SECTION

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

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 at 1-800-222-1222

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.
  • As referenced on the product labels.

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

Acrylate Crosspolymer, Triethanolamine, Vitamin E, Alovera extract, Ethyl Alcohol, Fragrance, Water

Uses

RECENT MAJOR CHANGES SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

observationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMediaobservationMedia

package label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

As mentioned below NDC codes

50 ml - 78985-001-01

89 ml - 78985-001-02

100 ml - 78985-001-03

200 ml - 78985-001-04

350 ml - 78985-001-08

500 ml - 78985-001-05

1000 ml - 78985-001-06

5000 ml - 78985-001-07

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78985-001-012022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-022022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-032022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-042022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-052022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-062022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-072022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-082022-01-28C16284748780-1d6a99b39-e211-a426-e053-dadaa90af4c2a7c2d766-9a59-9f61-e053-2a95a90ac4d4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78985-001-01Generic -Hand Sanitizer50 in 1 BOTTLEGEL501
78985-001-02Generic -Hand Sanitizer89 in 1 BOTTLEGEL891
78985-001-03Generic -Hand Sanitizer100 in 1 BOTTLEGEL1001
78985-001-04Generic -Hand Sanitizer200 in 1 BOTTLEGEL2001
78985-001-05Generic -Hand Sanitizer500 in 1 BOTTLEGEL5001
78985-001-06Generic -Hand Sanitizer1000 in 1 BOTTLEGEL10001
78985-001-07Generic -Hand Sanitizer5000 in 1 BOTTLEGEL50001
78985-001-08Generic -Hand Sanitizer350 in 1 BOTTLEGEL3501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78985-001GENERIC -HAND SANITIZER (GENERIC SPECIALTIES) GEL [GENERIC SPECIALTIES, INC.]1Legacy NDC, 8 package rows20200909_a7c2d766-9a59-9f61-e053-2a95a90ac4d4.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
78985-00178985-001-03, 78985-001-04, 78985-001-05, 78985-001-06, 78985-001-02, 78985-001-07, 78985-001-08, 78985-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a7c234b3-49e2-216c-e053-2995a90a0aa0a7c2d766-9a59-9f61-e053-2a95a90ac4d42020-07-25WarningsExact identifier
spl id: a7c234b3-49e2-216c-e053-2995a90a0aa0
spl set id: a7c2d766-9a59-9f61-e053-2a95a90ac4d4

Reported adverse events (FAERS/openFDA)#

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