FDA.reportPublic FDA data

SHCHS001

Manufacturer
Soap Hope
Effective date
2020-07-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:28

Label at a glance#

ProductSHCHS001
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

• Store between 15-30C(59-86F) • Avoid freezing and excessive heat above 40C(104F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

• on children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30C(59-86F)

• Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate cross polymer, aloe barbadensis leaf juice, glycerin, fragrance, tocopheryl acetate (vitamin E acetate)

SPL UNCLASSIFIED SECTION

- CLEAN STARTS WITH SOAP HOPE -

70% ETHYL ALCOHOL GEL SANITZER WITH VITAMIN E AND ALOE

Mission

INCLUSION + IMPACT

100% of proceeds from each purchase, including this one, support our mission of empowerment, independence and inclusion for individuals living with intellectual and/or developmental disabilities (IDD).

Soap Hope® is an MPact company. Learn more at soaphope.com or by scanning the code below.

Proudly produced and bottled in TX.

soaphope.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79088-101-012022-01-28C16284748780-1d6a99b39-42b7-a426-e053-dadaa90af4c2SOAP HOPE Hand Sanitizer
79088-101-042022-01-28C16284748780-1d6a99b39-42b7-a426-e053-dadaa90af4c2SOAP HOPE Hand Sanitizer
79088-101-142022-01-28C16284748780-1d6a99b39-42b7-a426-e053-dadaa90af4c2SOAP HOPE Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79088-101-01SHCHS0013785 mL in 1 BOTTLEGEL37852
79088-101-04SHCHS001118 mL in 1 BOTTLEGEL1182
79088-101-14SHCHS001473 mL in 1 BOTTLEGEL4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79088-101SHCHS001 (ETHYL ALCOHOL) GEL [SOAP HOPE]2Legacy NDC, 3 package rows20200715_dcd8abe9-3bda-40aa-9e4a-313fd322a34e.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
79088-10179088-101-04, 79088-101-14, 79088-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
5f528dd0-d4ac-40c1-af0a-8ccfc1d6d9eadcd8abe9-3bda-40aa-9e4a-313fd322a34e2020-07-11WarningsExact identifier
spl id: 5f528dd0-d4ac-40c1-af0a-8ccfc1d6d9ea
spl set id: dcd8abe9-3bda-40aa-9e4a-313fd322a34e

Reported adverse events (FAERS/openFDA)#

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