FDA.reportPublic FDA data

HUMASTE Hand Sanitizer

Manufacturer
Swanrose, Inc. | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD
Effective date
2020-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:45

Label at a glance#

ProductHUMASTE Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

• Hand sanitizer to reduce microorganisms on the skin. • Use this product when soap and water are not available.

Dosage and administration

• Read the entire label before using this product. • Place enough product on your palm to thoroughly cover your hands. • Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

• Hand sanitizer to reduce microorganisms on the skin.
• Use this product when soap and water are not available.

Warnings

WARNINGS SECTION

• For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician.

• 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Read the entire label before using this product.
• Place enough product on your palm to thoroughly cover your hands.
• Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerine, 1,2 Propylene Glycol, Carbomer, 2-Amino-2-Methyl Propanol

SPL UNCLASSIFIED SECTION

70% Alcohol
Self Drying Gel
Rub well until dry

Distributed & Marketed by Swanrose Inc.
SWANROSE, INC.
751 N. SPAULDING AVENUE
LOS ANGELES, CA 90046
PHONE: +1 (310) 266-5812
Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
78287-130-012022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-022022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-032022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-042022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-052022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-062022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-072022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-082022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-092022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-102022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer
78287-130-112022-01-28C16284748780-1d6a99b39-4287-a426-e053-dadaa90af4c2HUMASTE Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78287-130-01HUMASTE Hand Sanitizer50 mL in 1 BOTTLEGEL501
78287-130-02HUMASTE Hand Sanitizer60 mL in 1 BOTTLEGEL601
78287-130-03HUMASTE Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78287-130-04HUMASTE Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78287-130-05HUMASTE Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78287-130-06HUMASTE Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78287-130-07HUMASTE Hand Sanitizer560 mL in 1 BOTTLEGEL5601
78287-130-08HUMASTE Hand Sanitizer980 mL in 1 BOTTLEGEL9801
78287-130-09HUMASTE Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
78287-130-10HUMASTE Hand Sanitizer4000 mL in 1 BOTTLEGEL40001
78287-130-11HUMASTE Hand Sanitizer5000 mL in 1 CANGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78287-130HUMASTE HAND SANITIZER (ETHYL ALCOHOL) GEL [SWANROSE, INC.]1Legacy NDC, 11 package rows20200710_7ab6530a-4e1b-4080-84e5-a470d83a6d5d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78287-13078287-130-01, 78287-130-02, 78287-130-03, 78287-130-04, 78287-130-05, 78287-130-06, 78287-130-07, 78287-130-08, 78287-130-09, 78287-130-10, 78287-130-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
246f191e-126d-4a5b-9c44-f1809c3221aa7ab6530a-4e1b-4080-84e5-a470d83a6d5d2020-06-27WarningsExact identifier
spl id: 246f191e-126d-4a5b-9c44-f1809c3221aa
spl set id: 7ab6530a-4e1b-4080-84e5-a470d83a6d5d

Reported adverse events (FAERS/openFDA)#

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