FDA.reportPublic FDA data

Summit 375 Gel Alcohol Hand Sanitizer

Manufacturer
Dyno Manufacturing
Effective date
2021-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:40:00

Label at a glance#

ProductSummit 375 Gel Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on the skin 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin 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

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

OTHER SAFETY INFORMATION

-Store between 15-30C (59-86F).

-Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, phenoxyethanol,isopropyl myristate, glycerin, fragrance, Tertiary Butyl Alcohol, aminomethyl propanol, tocopheryl acetate, Denatonium Benzoate

Summit 375 Gel Alcohol Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79532-01479532-014-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATEQCD5R22RNTIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT

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
c7a4db79-e306-f524-e053-2a95a90a7a16bfdbbf2c-e4e3-bab7-e053-2a95a90a3c6e2021-07-21WarningsExact identifier
spl id: c7a4db79-e306-f524-e053-2a95a90a7a16
spl set id: bfdbbf2c-e4e3-bab7-e053-2a95a90a3c6e

Reported adverse events (FAERS/openFDA)#

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