FDA.reportPublic FDA data

Velnue

Manufacturer
Bodywell Natural Skin Care Inc
Effective date
2021-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:17

Label at a glance#

ProductVelnue
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.  For use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic.

Uses

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help reduce bacteria that potentially can cause disease. 
  • For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age.
• on open skin or wounds.

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

  • if irritation occurs.
  • These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions.

DOSAGE & ADMINISTRATION SECTION

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information.

SPL UNCLASSIFIED SECTION

• Store between 15-30C (59-86F)
• Avoid freezing & excessive heat above 40C(104F)

Inactive Ingredients.

INACTIVE INGREDIENT SECTION

Water, Bis-PEG-12 Dimethicone, Glycerin, PEG-7 Glyceryl Cocoate, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E)

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN1
616805ethanol 0.7 ML/ML Topical FoamSCD1
616805ethanol 70 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81441-004-012023-01-30C16284748780-1f386c649-f8f5-0266-e053-dadaa90a7c1aVelnue Foaming Hand Sanitizer Citrus Smile
81441-004-022023-01-30C16284748780-1f386c649-f8f5-0266-e053-dadaa90a7c1aVelnue Foaming Hand Sanitizer Citrus Smile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81441-004-01Velnue350 mL in 1 BOTTLE, PUMPLIQUID3501
81441-004-02Velnue1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81441-004VELNUE (ETHANOL) LIQUID [BODYWELL NATURAL SKIN CARE INC]1Legacy NDC, 2 package rows20210126_fb151bff-e716-4761-867b-f79180d7e79a.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
81441-00481441-004-01, 81441-004-02

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
WATER059QF0KO0RIACT
BIS-PEG-12 DIMETHICONE (70 MPA.S)2JDK5W22H4IACT
GLYCERINPDC6A3C0OXIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
GRAPEFRUIT OILYR377U58W9IACT
MANDARIN OILNJO720F72RIACT
BERGAMOT OIL39W1PKE3JIIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
b98c8c28-01fd-26ed-e053-2a95a90ad2c7fb151bff-e716-4761-867b-f79180d7e79a2021-01-23WarningsExact identifier
spl id: b98c8c28-01fd-26ed-e053-2a95a90ad2c7
spl set id: fb151bff-e716-4761-867b-f79180d7e79a

Reported adverse events (FAERS/openFDA)#

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