FDA.reportPublic FDA data

Rolhei 75 percent Ethanol Wet Wipe

Manufacturer
Glory Co., Ltd.
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:44

Label at a glance#

ProductRolhei 75 percent Ethanol Wet Wipe
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Dosage and administration

■ Wet hands thoroughly with product and allow to dry without wiping ■ Do not flush ■ Children under 2 years ask a doctor before use

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

WARNINGS

WARNINGS SECTION

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Wet hands thoroughly with product and allow to dry without wiping
■ Do not flush
■ Children under 2 years ask a doctor before use

Other information

OTHER SAFETY INFORMATION

■ Read the directions and warnings before use
■ Store between 15-30℃(59-89℉)
■ Avoid freezing and excessive heat above 40℃(104 ℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of packetImage of packet

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860004176305GTIN-13: 0860004176305
EAN-13: 0860004176305
GTIN-12: 860004176305
UPC-A: 860004176305
GTIN storage (14 digits): 00860004176305		100 packet.jpg
Data codeQR Codewww.rolhei.com100 packet.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78580-010-012022-01-28C16284748780-1d6a99b39-74cc-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78580-010-01Rolhei 75 percent Ethanol Wet Wipe100 in 1 PACKETCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78580-010ROLHEI 75 PERCENT ETHANOL WET WIPE (ALCOHOL) CLOTH [GLORY CO., LTD.]1Legacy NDC, 1 package rows20200616_0479f4af-249e-446f-b84a-c8bd101db586.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
78580-01078580-010-01

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
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
GlycerinPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
275ef60b-3c74-4756-9dc7-c0005be4c4e50479f4af-249e-446f-b84a-c8bd101db5862020-06-16WarningsExact identifier
spl id: 275ef60b-3c74-4756-9dc7-c0005be4c4e5
spl set id: 0479f4af-249e-446f-b84a-c8bd101db586

Reported adverse events (FAERS/openFDA)#

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