FDA.reportPublic FDA data

Advanced Gel Hand Sanitizer soothing Lavender

Manufacturer
BLUETRACK INC | NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD
Effective date
2021-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:22

Label at a glance#

ProductAdvanced Gel Hand Sanitizer soothing Lavender
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Apply Small amount in your palm and briskly rub hands together until dry.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol Alcohol 62% w/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Advanced Hand Sanitizer Soothing Lavender

Use

INDICATIONS & USAGE SECTION

For Sanitizing hands to reduce bacteria and virus on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children or pets.

OTC - WHEN USING SECTION

Do not put in eyes

Directions

DOSAGE & ADMINISTRATION SECTION

Apply Small amount in your palm and briskly rub hands together until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Water, Glycerin, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Vitamin E, Iron Oxide(CI 77499),Iron Oxide(CI 77492), D&C Red No.30.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60mL NDC : 81209-200-03 60mL60mL

5000 mL NDC: 81209-200-01

1000mL NDC: 81209-200-02

5000mL5000mL1000mL1000mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN3
581660ethanol 0.62 ML/ML Topical GelSCD3
581660ethanol 62 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81209-200-012023-01-30C16284748780-1f386c64a-024f-0266-e053-dadaa90a7c1aAdvanced Gel HAND SANITIZER Soothing Lavender
81209-200-022023-01-30C16284748780-1f386c64a-024f-0266-e053-dadaa90a7c1aAdvanced Gel HAND SANITIZER Soothing Lavender
81209-200-032023-01-30C16284748780-1f386c64a-024f-0266-e053-dadaa90a7c1aAdvanced Gel HAND SANITIZER Soothing Lavender

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81209-200-01Advanced Gel Hand Sanitizer soothing Lavender5000 mL in 1 BOTTLEGEL50003
81209-200-02Advanced Gel Hand Sanitizer soothing Lavender1000 mL in 1 BOTTLE, PUMPGEL10003
81209-200-03Advanced Gel Hand Sanitizer soothing Lavender60 mL in 1 BOTTLE, DISPENSINGGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81209-200ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER (ETHANOL ALCOHOL) GEL [BLUETRACK INC]3Legacy NDC, 3 package rows20210915_b5b3d70e-abaf-ee11-e053-2995a90a79ff.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
81209-20081209-200-01, 81209-200-02, 81209-200-03

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
D&C RED NO. 302S42T2808BIACT
ALOE VERA LEAFZY81Z83H0XIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
TOCOPHEROLR0ZB2556P8IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FRAGRANCE LAVENDER ORC18009791B40MIN2W5IACT

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
ca0b4986-5b06-199d-e053-2a95a90aafeab5b3d70e-abaf-ee11-e053-2995a90a79ff2021-08-21WarningsExact identifier
spl id: ca0b4986-5b06-199d-e053-2a95a90aafea
spl set id: b5b3d70e-abaf-ee11-e053-2995a90a79ff

Reported adverse events (FAERS/openFDA)#

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