FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SMARKCHEM INDUSTRIES INC
Effective date
2020-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:28

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

SPL UNCLASSIFIED SECTION

  1. Isopropyl Alcohol (75%, v/v)
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. water

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 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

glycerin, hydrogen peroxide, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.785 L NDC: 75812-7500-01

3.785 L label3.785 L label

473 ml NDC: 75812-750-17

473 ml Label473 ml Label

473 ml NDC 75812-750-16

473 ml Label473 ml Label

946 ml NDC 75812-750-32

946 ml Label946 ml Label

18.927 L NDC: 75812-750-06

18.927 L Label18.927 L Label

18.927 L NDC: 75812-750-05

18.927 L Label18.927 L Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN2
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD2
1039900isopropyl alcohol 75 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75812-750-012022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer
75812-750-052022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer
75812-750-062022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer
75812-750-162022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer
75812-750-172022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer
75812-750-322022-01-28C16284748780-1d6a99b39-be69-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75812-750-01Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37852
75812-750-05Hand Sanitizer18927 mL in 1 CONTAINERLIQUID189272
75812-750-06Hand Sanitizer18927 mL in 1 PAILLIQUID189272
75812-750-16Hand Sanitizer473.176 mL in 1 BOTTLE, SPRAYLIQUID473.1762
75812-750-17Hand Sanitizer473.176 mL in 1 BOTTLE, PLASTICLIQUID473.1762
75812-750-32Hand Sanitizer946.353 mL in 1 BOTTLE, SPRAYLIQUID946.3532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75812-750HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [SMARKCHEM INDUSTRIES INC]2Legacy NDC, 6 package rows20200423_a3d31e3b-bf5b-ae57-e053-2a95a90a86ae.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75812-75075812-750-01, 75812-750-06, 75812-750-32, 75812-750-16, 75812-750-05, 75812-750-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a3d31cfb-fae6-a735-e053-2a95a90a595ba3d31e3b-bf5b-ae57-e053-2a95a90a86ae2020-04-21WarningsExact identifier
spl id: a3d31cfb-fae6-a735-e053-2a95a90a595b
spl set id: a3d31e3b-bf5b-ae57-e053-2a95a90a86ae

Reported adverse events (FAERS/openFDA)#

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