FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Super Dope Laboratories LLC
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:19:02

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure22 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#

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

Water, Carbomer 940, Glycerin, Hydrogen Peroxide, Trolamine, Linalool, Lavender Oil (Fragrance)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60mL NDC: 74220-003-01 60mL60mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120mL NDC: 74220-003-03 120mL120mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100mL NDC: 74220-003-02 100mL100mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mL NDC: 74220-003-04

500mL500mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

750mL NDC: 74220-003-05 750mL750mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000mL NDC: 74220-003-06 1000mL1000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2mL NDC 74220-003-07 2mL2mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 Count NDC 74220-003-17

100 Count100 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3790mL NDC 74220-003-08

GallonGallon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

275G NDC: 74220-003-09

275G275G

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 74220-003-10

355mL

355ml355ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237mL (8oz) NDC: 74220-003-11

237mL237mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN6
581662ethanol 0.7 ML/ML Topical GelSCD6
581662ethanol 70 % Topical GelSY6
581662ethyl alcohol 70 % Topical GelSY6

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
74220-003-012022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-022022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-032022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-042022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-052022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-062022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-082022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-092022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-102022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-112022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin
74220-003-172022-01-28C16284748780-1d6a99b39-c3d0-a426-e053-dadaa90af4c2Fuggin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74220-003-01Hand Sanitizer60 mL in 1 BOTTLEGEL606
74220-003-02Hand Sanitizer100 mL in 1 BOTTLEGEL1006
74220-003-03Hand Sanitizer120 mL in 1 BOTTLEGEL1206
74220-003-04Hand Sanitizer500 mL in 1 BOTTLEGEL5006
74220-003-05Hand Sanitizer750 mL in 1 BOTTLEGEL7506
74220-003-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10006
74220-003-07Hand Sanitizer2 mL in 1 PACKETGEL26
74220-003-08Hand Sanitizer3790 mL in 1 BOTTLEGEL37906
74220-003-09Hand Sanitizer1419528.75 mL in 1 DRUMGEL1419528.756
74220-003-10Hand Sanitizer355 mL in 1 BOTTLEGEL3556
74220-003-11Hand Sanitizer237 mL in 1 BOTTLEGEL2376
74220-003-17Hand Sanitizer100 in 1 BOXGEL1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74220-003HAND SANITIZER (ALCOHOL) GEL [SUPER DOPE LABORATORIES LLC]6Legacy NDC, 12 package rows20200626_a46bb5dd-572c-7454-e053-2995a90a8d6d.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
74220-00374220-003-01, 74220-003-03, 74220-003-04, 74220-003-05, 74220-003-06, 74220-003-07, 74220-003-17, 74220-003-02, 74220-003-08, 74220-003-09, 74220-003-10, 74220-003-11

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
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
LINALOOL, (+/-)-D81QY6I88EIACT
TROLAMINE9O3K93S3TKIACT
LAVENDER OILZBP1YXW0H8IACT

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
a8efa611-273b-2912-e053-2995a90a3d96a46bb5dd-572c-7454-e053-2995a90a8d6d2020-06-25WarningsExact identifier
spl id: a8efa611-273b-2912-e053-2995a90a3d96
spl set id: a46bb5dd-572c-7454-e053-2995a90a8d6d

Reported adverse events (FAERS/openFDA)#

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