FDA.reportPublic FDA data

Summit 375 Gel Alcohol Hand Sanitizer

Product NDC
23590-400
11-digit product format
235900400
Labeler code
23590
Product ID
23590-400_509cd5d6-2791-73d1-e063-6294a90addda
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
R.L. Williams Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-29
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Summit 375 Gel Alcohol Hand SanitizerALCOHOLR.L. Williams Company509cc442-09f8-d17f-e063-6394a90a77ea2026-04-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Flammable, keep away from fire or flame . For external use only . When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact a doctor immediately. Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Summit 375 Gel Alcohol Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23590-400-10Summit 375 Gel Alcohol Hand Sanitizer850 mL in 1 BOTTLE, PUMPGEL8501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN509cc442-09f8-d17f-e063-6394a90a77ea1
581662ethanol 0.7 ML/ML Topical GelSCD509cc442-09f8-d17f-e063-6394a90a77ea1
581662ethanol 70 % Topical GelSY509cc442-09f8-d17f-e063-6394a90a77ea1
581662ethyl alcohol 70 % Topical GelSY509cc442-09f8-d17f-e063-6394a90a77ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23590-400-1023590040010850 mL in 1 BOTTLE, PUMP (23590-400-10) 850 ml2026-04-29NoNoCurrent