FDA.reportPublic FDA data

ACP Hand sanitizer

Manufacturer
Swanrose, Inc.
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#

ProductACP 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 73%

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

Aqua, Glycerin, Carbomer, Triethanolamine

SPL UNCLASSIFIED SECTION

73% 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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286987ethanol 73 % Topical GelPSN1
2286987ethanol 0.73 ML/ML Topical GelSCD1
2286987ethanol 73 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78287-160-012022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-022022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-032022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-042022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-052022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-062022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-072022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-082022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-092022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-102022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer
78287-160-112022-01-28C16284748780-1d6a99b39-dde6-a426-e053-dadaa90af4c2ACP Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78287-160-01ACP Hand sanitizer29 mL in 1 BOTTLEGEL291
78287-160-02ACP Hand sanitizer60 mL in 1 BOTTLEGEL601
78287-160-03ACP Hand sanitizer80 mL in 1 BOTTLEGEL801
78287-160-04ACP Hand sanitizer100 mL in 1 BOTTLEGEL1001
78287-160-05ACP Hand sanitizer250 mL in 1 BOTTLEGEL2501
78287-160-06ACP Hand sanitizer260 mL in 1 BOTTLEGEL2601
78287-160-07ACP Hand sanitizer300 mL in 1 BOTTLEGEL3001
78287-160-08ACP Hand sanitizer500 mL in 1 BOTTLEGEL5001
78287-160-09ACP Hand sanitizer980 mL in 1 BOTTLEGEL9801
78287-160-10ACP Hand sanitizer3785 mL in 1 BOTTLEGEL37851
78287-160-11ACP Hand sanitizer5000 mL in 1 CANGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78287-160ACP HAND SANITIZER (ETHYL ALCOHOL) GEL [SWANROSE, INC.]1Legacy NDC, 11 package rows20200710_38c62375-9d26-4de6-aeb4-f4177a7d662a.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
78287-16078287-160-01, 78287-160-02, 78287-160-03, 78287-160-04, 78287-160-05, 78287-160-06, 78287-160-07, 78287-160-08, 78287-160-09, 78287-160-10, 78287-160-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT

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
9af2a501-b2de-4c3e-8e70-489cc4df90dd38c62375-9d26-4de6-aeb4-f4177a7d662a2020-06-27WarningsExact identifier
spl id: 9af2a501-b2de-4c3e-8e70-489cc4df90dd
spl set id: 38c62375-9d26-4de6-aeb4-f4177a7d662a

Reported adverse events (FAERS/openFDA)#

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