Sanigen

Manufacturer
WORLDCHEM CO LTD
Effective date
2020-05-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:24

Label at a glance#

ProductSanigen
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ethanol (synthetic alcohol) 70%

INACTIVE INGREDIENT SECTION

Water, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate, L-menthol, Lemon oil

OTC - PURPOSE SECTION

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

WARNINGS SECTION

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep Out of Reach of Children.

INDICATIONS & USAGE SECTION

■ spray a small amount into hands, spread evenly and rub into the skin

DOSAGE & ADMINISTRATION SECTION

for topical use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN2
1041849ethanol 0.7 ML/ML Topical SpraySCD2
1041849ethanol 70 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74538-0005-12022-07-29C16284748780-1e4f33bdf-a58f-d8a0-e053-dadaa90a6e4ea276c93f-4353-b33c-e053-2a95a90a03b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74538-0005-1Sanigen50 mL in 1 BOTTLESPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74538-0005SANIGEN (ALCOHOL) SPRAY [WORLDCHEM CO LTD]2Legacy NDC, 1 package rows20200531_a276c93f-4353-b33c-e053-2a95a90a03b3.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74538-000574538-0005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
a6d79b3f-8bff-650f-e053-2995a90a4684a276c93f-4353-b33c-e053-2a95a90a03b32020-05-30WarningsExact identifier
spl id: a6d79b3f-8bff-650f-e053-2995a90a4684
spl set id: a276c93f-4353-b33c-e053-2a95a90a03b3

Reported adverse events (FAERS/openFDA)#

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