FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Davemed Healthcare Co., Ltd
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:55

Label at a glance#

ProductInstant Hand Sanitizer 70% Alcohol
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use

Storage and handling

Do not store above 105F May discolor some fabrics. Harmful to wood finishes and plastics

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) (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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable.

Keep away from fire or flame

For external use only

When using this product

  • avoid contact with eyes
  • in case of eye contact, immediately flush eyes with water, call a doctor
  • avoid contact with broken skin

Discontinue use if irrittion or redness develops. If condition persists for more than 72 hours, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children should only use this product under adult supervision

Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105F
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe bardensis leaf extract, caprylyl glycol carbomer, glycerin, isopropyl alcohol, isopropyl myristate, hydrochloric acid, sodium chloride

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70897-009-012024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-022024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-032024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-042024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-052024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-062024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-072024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-082024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-092024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer
70897-009-102024-01-30C16284748780-11030e365-3ccf-111a-e063-dadaa90a10e2Instant Hand Santizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70897-009-01Instant Hand Sanitizer70% Alcohol250 mL in 1 BOTTLELIQUID2502
70897-009-02Instant Hand Sanitizer70% Alcohol60 mL in 1 BOTTLELIQUID602
70897-009-03Instant Hand Sanitizer70% Alcohol80 mL in 1 BOTTLELIQUID802
70897-009-04Instant Hand Sanitizer70% Alcohol100 mL in 1 BOTTLELIQUID1002
70897-009-05Instant Hand Sanitizer70% Alcohol200 mL in 1 BOTTLELIQUID2002
70897-009-06Instant Hand Sanitizer70% Alcohol300 mL in 1 BOTTLELIQUID3002
70897-009-07Instant Hand Sanitizer70% Alcohol500 mL in 1 BOTTLELIQUID5002
70897-009-08Instant Hand Sanitizer70% Alcohol1000 mL in 1 BOTTLELIQUID10002
70897-009-09Instant Hand Sanitizer70% Alcohol3780 mL in 1 BOTTLELIQUID37802
70897-009-10Instant Hand Sanitizer70% Alcohol5000 mL in 1 BOTTLELIQUID50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70897-009INSTANT HAND SANITIZER 70% ALCOHOL (ALCOHOL) LIQUID [DAVEMED HEALTHCARE CO., LTD]2Legacy NDC, 10 package rows20200703_a2420501-757b-8634-e053-2a95a90af068.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70897-00970897-009-01, 70897-009-02, 70897-009-03, 70897-009-04, 70897-009-05, 70897-009-06, 70897-009-07, 70897-009-08, 70897-009-09, 70897-009-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCHLORIC ACIDQTT17582CBIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
a97b4887-7086-4d38-e053-2995a90a282fa2420501-757b-8634-e053-2a95a90af0682020-07-02WarningsExact identifier
spl id: a97b4887-7086-4d38-e053-2995a90a282f
spl set id: a2420501-757b-8634-e053-2a95a90af068

Reported adverse events (FAERS/openFDA)#

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