FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Southern Telecom, Inc.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:17:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only, do not inhale or ingest.

Do not use

OTC - DO NOT USE SECTION

in, or near the eyes. In case of contact with eyes, rinse thoroughly with water.

Avoid contact with broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develops, irritation or rash develop and persist for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Carbomer, Aloe Vera Gel, Fragrance, Glycerin, Propylene Glycol

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN3
1047755ethanol 0.75 ML/ML Topical SolutionSCD3
1047755ethanol 75 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76546-001-012022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-022022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-032022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-082022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-102022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-162022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-342022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-352022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-362022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer
76546-001-372022-01-28C16284748780-1d6a99b39-5a7d-a426-e053-dadaa90af4c2Cleanology, Colorways, Advanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76546-001-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID303
76546-001-02Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID603
76546-001-03Hand Sanitizer30 mL in 1 TUBELIQUID303
76546-001-08Hand Sanitizer250 mL in 1 BOTTLE, PUMPLIQUID2503
76546-001-10Hand Sanitizer300 mL in 1 BOTTLE, PUMPLIQUID3003
76546-001-16Hand Sanitizer500 mL in 1 BOTTLE, PUMPLIQUID5003
76546-001-34Hand Sanitizer10 mL in 1 BOTTLE, SPRAYLIQUID103
76546-001-35Hand Sanitizer20 mL in 1 BOTTLE, SPRAYLIQUID203
76546-001-36Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID603
76546-001-37Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76546-001HAND SANITIZER (ALCOHOL) LIQUID [SOUTHERN TELECOM, INC.]3Legacy NDC, 10 package rows20200611_a6427617-fae5-451d-e053-2a95a90aac25.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76546-00176546-001-01, 76546-001-02, 76546-001-10, 76546-001-16, 76546-001-03, 76546-001-08, 76546-001-34, 76546-001-35, 76546-001-36, 76546-001-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
a7c08d39-8adc-1afa-e053-2995a90a59c9a6427617-fae5-451d-e053-2a95a90aac252020-06-10WarningsExact identifier
spl id: a7c08d39-8adc-1afa-e053-2995a90a59c9
spl set id: a6427617-fae5-451d-e053-2a95a90aac25

Reported adverse events (FAERS/openFDA)#

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