Sanitizing Hand

Manufacturer
BELLA BRANDS INC
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:00

Label at a glance#

ProductSanitizing Hand
Active ingredientAlcohol
Label structure8 sections

Dosage and administration

- Press dispensing pump to release product into hand, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry. - For adults and children 2 years and over. - For children under 2 years of age, consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% V/V

Purpose

OTC - PURPOSE SECTION

Antimicrobial Agent

Use

INDICATIONS & USAGE SECTION

for cleaning hands and decreasing bacteria on the skin.

Warnings

WARNINGS SECTION

- For external use only.

- Do not use if you are allergic to any of the ingredients.

- When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.

- Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbopol, Tocopherol, Aloe Vera Barbadensis Leaf Juice1, Chamomilla Recutita (Matricaria) Flower Extract1, Camelia Sinensis Leaf Extract1, Vitis Vinifera (Grapeseed) Extract1, Helianthus Annuus (Sunflower) Seed Oil1, Fragrance (Naturally Derived), Sodium Hydroxide

1 Organic Ingredient

Directions for Use

DOSAGE & ADMINISTRATION SECTION

- Press dispensing pump to release product into hand, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry.

- For adults and children 2 years and over.

- For children under 2 years of age, consult a doctor before use.

PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURIGEN™

Sanitizing
Hand Gel

  • Kills 99.9% of Germs
  • Safe for Sensitive Skin
  • 70% Alcohol Formula

Paraben Free
No Artificial Fragrance
Made with Organic Ingredients

13.5 fl oz (400 ml)

Principal Display Panel - 400 ml Bottle Label
Principal Display Panel - 400 ml Bottle Label

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
80994-001-012022-01-28C16284748780-1d6a99b39-ccc6-a426-e053-dadaa90af4c2Sanitizing Hand
80994-001-022022-01-28C16284748780-1d6a99b39-ccc6-a426-e053-dadaa90af4c2Sanitizing Hand
80994-001-032022-01-28C16284748780-1d6a99b39-ccc6-a426-e053-dadaa90af4c2Sanitizing Hand
80994-001-042022-01-28C16284748780-1d6a99b39-ccc6-a426-e053-dadaa90af4c2Sanitizing Hand

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80994-001-01Sanitizing Hand250 mL in 1 BOTTLEGEL2501
80994-001-02Sanitizing Hand400 mL in 1 BOTTLEGEL4001
80994-001-03Sanitizing Hand3785 mL in 1 BOTTLEGEL37851
80994-001-04Sanitizing Hand1.2 mL in 1 PACKETGEL1.21
80994-001-04Sanitizing Hand150 in 1 BOXGEL1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80994-001SANITIZING HAND (ALCOHOL) GEL [BELLA BRANDS INC]1Legacy NDC, 5 package rows20201121_36548baa-1e6d-49f4-a969-a1d20fcf5f81.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80994-00180994-001-01, 80994-001-02, 80994-001-03, 80994-001-04

Ingredients#

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

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

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
e5c1e733-6613-4318-9525-d77af2b62a4336548baa-1e6d-49f4-a969-a1d20fcf5f812020-11-18WarningsExact identifier
spl id: e5c1e733-6613-4318-9525-d77af2b62a43
spl set id: 36548baa-1e6d-49f4-a969-a1d20fcf5f81

Reported adverse events (FAERS/openFDA)#

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