FDA.reportPublic FDA data

BIOCARE LABS CLEAN HAND SANITIZER

Manufacturer
BIOCARE LABS INC. | Suraz Corporation Inc.
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:32

Label at a glance#

ProductBIOCARE LABS CLEAN HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand Sanitizer to help decrease bacteria on the skin.

Dosage and administration

• Wet hands thoroughly with product. • Briskly rub hands together until dry. • Supervise children under the age of 6 when using this product

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70% v/v 

Uses:

OTC - PURPOSE SECTION

Hand Sanitizer to help decrease bacteria on the skin.

Warnings:

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use:

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if: if irritation or redness develop and lasts.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Wet hands thoroughly with product.

• Briskly rub hands together until dry.

• Supervise children under the age of 6 when using this product

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Deionized Water (Aqua, Eau), Glycerine, Melaleuca Alternafolia (Tea Tree) Leaf Oil,

Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl
Propanol, Acrylates Copolymer, Fragrance (Parfum), Polysorbate-20

Other Information:

SPL UNCLASSIFIED SECTION

• Store at 20°C to 25 °C (68° – 77° F)
• May discolor certain surfaces or fabrics.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clean Hand Sanitizer 2.0 FL OZClean Hand Sanitizer 2.0 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clean Hand Sanitizer PacketClean Hand Sanitizer Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54602-100-002022-01-28C16284748780-1d6a99b39-62f8-a426-e053-dadaa90af4c2BIOCARE LABS CLEAN HAND SANITIZER
54602-100-012022-01-28C16284748780-1d6a99b39-62f8-a426-e053-dadaa90af4c2BIOCARE LABS CLEAN HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54602-100-00BIOCARE LABS CLEAN HAND SANITIZER0.060 L in 1 BOTTLEGEL0.0601
54602-100-01BIOCARE LABS CLEAN HAND SANITIZER0.0072 L in 1 BLISTER PACKGEL0.00721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54602-100BIOCARE LABS CLEAN HAND SANITIZER (ETHYL ALCOHOL 70% V/V) GEL [BIOCARE LABS INC.]1Legacy NDC, 2 package rows20201014_7a74262d-9125-4a9b-8e58-81aaca96a91c.zip

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
54602-10054602-100-00, 54602-100-01

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER 9404Q93RCW27EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
POLYSORBATE 207T1F30V5YHIACT

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
6db5d2b2-7dab-4c53-bd8e-a6e1d623a2677a74262d-9125-4a9b-8e58-81aaca96a91c2020-10-05WarningsExact identifier
spl id: 6db5d2b2-7dab-4c53-bd8e-a6e1d623a267
spl set id: 7a74262d-9125-4a9b-8e58-81aaca96a91c

Reported adverse events (FAERS/openFDA)#

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