FDA.reportPublic FDA data

SunDrops 75

Manufacturer
Sunburst Chemicals, Inc.
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:43:20

Label at a glance#

ProductSunDrops 75
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Place 5 grams or palmful of product in one hand. Spread on hands and run into skin until dry. Place a smaller amount (2.5 grams) in one hand and spread over both hands and wrists. Rub into skin until dry. Children should be supervised while using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 60% v/v

Purpose

OTC - PURPOSE SECTION

Skin Sanitizer

Use

INDICATIONS & USAGE SECTION

To help reduce amount of bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only. If swallowed, seek medical attention.

When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact doctor immediately.

Stop use and consult a doctor when skin irritation appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place 5 grams or palmful of product in one hand.
  • Spread on hands and run into skin until dry.
  • Place a smaller amount (2.5 grams) in one hand and spread over both hands and wrists.
  • Rub into skin until dry.
  • Children should be supervised while using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label - 8 fl. oz. Bottle Top LabelPackage Label - 8 fl. oz. Bottle Top Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN10
581658ethanol 0.6 ML/ML Topical GelSCD10
581658ethanol 60 % Topical GelSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63621-356-14SunDrops 753785 mL in 1 BOTTLE, PLASTICGEL378510
63621-356-20SunDrops 751000 mL in 1 BAGGEL100010
63621-356-20SunDrops 758 in 1 BOXGEL810
63621-356-25SunDrops 7512 in 1 BOXGEL1210
63621-356-25SunDrops 75236.6 mL in 1 BOTTLE, PUMPGEL236.610
63621-356-30SunDrops 756 in 1 BOXGEL610
63621-356-30SunDrops 751000 mL in 1 BAGGEL100010
63621-356-40SunDrops 751000 mL in 1 BAGGEL100010
63621-356-40SunDrops 754 in 1 BOXGEL410
63621-356-50SunDrops 75473.2 mL in 1 BOTTLE, PUMPGEL473.210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63621-35663621-356-20, 63621-356-25, 63621-356-30, 63621-356-14, 63621-356-50, 63621-356-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
DIISOPROPYLAMINEBR9JLI40NOIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-03-21full-release2026-06-01 00:10:10

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
SunDrops 75ALCOHOLSunburst Chemicals, Inc.b0623424-939e-4b49-aa99-c1ef22cf0f2d2025-11-11WarningsExact identifier
ndc (package): 63621-356-40
ndc (package): 63621-356-50
ndc (package): 63621-356-20
ndc (package): 63621-356-14
ndc (package): 63621-356-25
ndc (package): 63621-356-30
ndc (product): 63621-356
ndc11 (package): 63621035630
ndc11 (package): 63621035650
ndc11 (package): 63621035620
ndc11 (package): 63621035625
ndc11 (package): 63621035614
ndc11 (package): 63621035640
spl id: 435330fc-c021-151b-e063-6394a90a229b
spl set id: b0623424-939e-4b49-aa99-c1ef22cf0f2d

Reported adverse events (FAERS/openFDA)#

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