Protect By Hand Sanitizer gel (ethanol)

Manufacturer
Ken Company Co., Ltd. | Skin n Skin Co., Ltd.
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:20

Label at a glance#

ProductProtect By Hand Sanitizer gel (ethanol)
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

alcohol

INACTIVE INGREDIENT SECTION

Water
Glycerin
Carbomer
Triethanolamine
Rosmarinus Officinalis (Rosemary) Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Rose Centifolia Flower Water
Citrus Aurantium Dulcis (Orange) Oil
Limonene

OTC - PURPOSE SECTION

Sterilization of hands and skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

Apply an appropriate amount on your hands and rub well to dry.

WARNINGS SECTION

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
7) Do not use for any other purpose.
4. Precautions for storage
1) Avoid shading and keep in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
Objects.

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
80594-0001-12022-01-28C16284748780-1d6a99b39-61b0-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80594-0001-1Protect By Hand Sanitizer gel (ethanol)60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80594-0001PROTECT BY HAND SANITIZER GEL (ETHANOL) (ALCOHOL) GEL [KEN COMPANY CO., LTD.]1Legacy NDC, 1 package rows20200915_af51cc6b-eda6-dd90-e053-2995a90a508d.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80594-000180594-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
af51c93b-c287-74f7-e053-2a95a90ac8a5af51cc6b-eda6-dd90-e053-2995a90a508d2020-09-14WarningsExact identifier
spl id: af51c93b-c287-74f7-e053-2a95a90ac8a5
spl set id: af51cc6b-eda6-dd90-e053-2995a90a508d

Reported adverse events (FAERS/openFDA)#

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