Hand Sanitizer

Manufacturer
Shedrain Corporation | XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD
Effective date
2020-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:18

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

Storage and handling

Store below 110°F (43°C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%. Purpose: Antimicrobial

Active ingredientActive ingredient

Purpose

OTC - PURPOSE SECTION

Hand sanitizer to help decrease bacteria on the skin.

PurposePurpose

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

WarningWarning

Do not use

OTC - DO NOT USE SECTION

Do not use in or near the eyes. If contact occurs, flush thoroughly with water. Do not useDo not use

OTC - STOP USE SECTION

Stop use and contact doctor if redness and irritation develops and persists.

Stop useStop use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Keep out of childrenKeep out of children

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

Dosage & AdminDosage & Admin

Other information

STORAGE AND HANDLING SECTION

Store below 110°F (43°C)

Other infoOther info

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Animomethyl Propanol, Aloe Barbadensis Leaf Extract.

Inactive ingredientInactive ingredient

INDICATIONS & USAGE SECTION

Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

IndicateIndicate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Instant Hand Sanitizer. 50mL

Package labelPackage 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
80380-071-012022-01-28C16284748780-1d6a99b39-971c-a426-e053-dadaa90af4c2b2214b3c-3a5b-5dc5-e053-2995a90ab680

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80380-071-01Hand Sanitizer70 mL in 1 BOTTLE, DISPENSINGGEL701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80380-071HAND SANITIZER (ALCOHOL) GEL [SHEDRAIN CORPORATION]1Legacy NDC, 1 package rows20201023_b2214b3c-3a5b-5dc5-e053-2995a90ab680.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80380-07180380-071-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
b2214b3c-3a4d-5dc5-e053-2995a90ab680b2214b3c-3a5b-5dc5-e053-2995a90ab6802020-10-23WarningsExact identifier
spl id: b2214b3c-3a4d-5dc5-e053-2995a90ab680
spl set id: b2214b3c-3a5b-5dc5-e053-2995a90ab680

Reported adverse events (FAERS/openFDA)#

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