FDA.reportPublic FDA data

Clean X Premium Instant Hand Cleanser

Manufacturer
DreamDream international
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:14

Label at a glance#

ProductClean X Premium Instant Hand Cleanser
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Uses: Hand sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

Directions: • Put a small drop onto palm of your hand and massage hands together until dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: ALCOHOL 70% w/w

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, Glycerin, Triethanolamine, Aloe Barbadensis Leaf Extract, Carbomer, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Flavor, Disodium EDTA, Isopropyl Alcohol, Decyl Glucoside

PURPOSE

OTC - PURPOSE SECTION

Purpose: ANTISEPTIC

WARNINGS

WARNINGS SECTION

Warnings:

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in 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 or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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.

Uses

INDICATIONS & USAGE SECTION

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

• Put a small drop onto palm of your hand and massage hands together until dry.

Other information

OTHER SAFETY INFORMATION

Other information:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809086082533GTIN-13: 8809086082533
EAN-13: 8809086082533
GTIN storage (14 digits): 08809086082533		500 bottle.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76682-010-012022-01-28C16284748780-1d6a99b39-d7e5-a426-e053-dadaa90af4c2c56116db-a924-45ea-8470-179813b3bf8b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76682-010-01Clean X Premium Instant Hand Cleanser500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76682-010CLEAN X PREMIUM INSTANT HAND CLEANSER (ALCOHOL) GEL [DREAMDREAM INTERNATIONAL]1Legacy NDC, 1 package rows20200501_c56116db-a924-45ea-8470-179813b3bf8b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76682-01076682-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PEG-60 Hydrogenated Castor Oil02NG325BQGIACT
PhenoxyethanolHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
Isopropyl AlcoholND2M416302IACT
Decyl GlucosideZ17H97EA6YIACT

Source Document#

Source XML · Source PDF

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
57eb4a61-fcd1-4b27-bd38-2e6cef34c938c56116db-a924-45ea-8470-179813b3bf8b2020-05-01WarningsExact identifier
spl id: 57eb4a61-fcd1-4b27-bd38-2e6cef34c938
spl set id: c56116db-a924-45ea-8470-179813b3bf8b

Reported adverse events (FAERS/openFDA)#

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