FDA.reportPublic FDA data

TopCare Prebiotic Hand Sanitizer

Manufacturer
TopCo Associates LLC | Apollo Health and Beauty Care Inc.
Effective date
2019-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:07

Label at a glance#

ProductTopCare Prebiotic Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

to help reduce bacteria on the skin

Dosage and administration

put enough hand sanitizer in your palm to cover hands and rub hands together until dry. children under 6 years should be supervised when using this product.

Storage and handling

store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

  • Flammable
  • Keep away from source of heat or fire

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

irritation or redness develops and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • put enough hand sanitizer in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

Image of the label 8ozImage of the label 8oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
884783ethanol 65 % Topical SolutionPSN1
884783ethanol 0.65 ML/ML Topical SolutionSCD1
884783ethanol 65 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-996-022021-01-29C16284748780-1ba0f9c33-28ba-a910-e053-dadaa90a0b85Drug Facts
36800-996-082021-01-29C16284748780-1ba0f9c33-28ba-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-996-02TopCare Prebiotic Hand Sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
36800-996-08TopCare Prebiotic Hand Sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-996TOPCARE PREBIOTIC HAND SANITIZER (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 2 package rows20190822_290f7873-249f-4279-a7d3-a3caae5d92d2.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-99636800-996-08, 36800-996-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER 934Z135WT9208IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
c2f14f07-06ba-4de5-8c73-95acc6f48f79290f7873-249f-4279-a7d3-a3caae5d92d22019-08-21WarningsExact identifier
spl id: c2f14f07-06ba-4de5-8c73-95acc6f48f79
spl set id: 290f7873-249f-4279-a7d3-a3caae5d92d2

Reported adverse events (FAERS/openFDA)#

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