FDA.reportPublic FDA data

PPE361 ALCOHOL WIPE 1

Manufacturer
ITECH 361 LLC | ZHEJIANG BRIGHT COMMODITY CO LTD
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:48

Label at a glance#

ProductPPE361 ALCOHOL WIPE 1
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Instant hand antiseptic to decrease bacteria on skin.

Dosage and administration

■ Wet hands thoroughly. Allow to dry without wiping. ■ Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

Instant hand antiseptic to decrease bacteria on skin.

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

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

■ Wet hands thoroughly. Allow to dry without wiping.

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

■ Store between 15-30°C (59-86°F)

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua).

PPE361 ALCOHOL WIPE 1 (NDC 74871-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iTech361 LLC PPE361 Alcohol Wipe 1iTech361 LLC PPE361 Alcohol Wipe 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1307051ethyl alcohol 75 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74871-001-002022-07-29C16284748780-1e4f33bdf-ac44-d8a0-e053-dadaa90a6e4eITECH361 PPE361 ALCOHOL WIPE 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74871-001-00PPE361 ALCOHOL WIPE 11 mL in 1 PACKETCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74871-001PPE361 ALCOHOL WIPE 1 (ETHYL ALCOHOL) CLOTH [ITECH 361 LLC]1Legacy NDC, 1 package rows20210112_b8a9b659-743c-7acb-e053-2a95a90ac4a3.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74871-00174871-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b8a9b659-743d-7acb-e053-2a95a90ac4a3b8a9b659-743c-7acb-e053-2a95a90ac4a32021-01-08WarningsExact identifier
spl id: b8a9b659-743d-7acb-e053-2a95a90ac4a3
spl set id: b8a9b659-743c-7acb-e053-2a95a90ac4a3

Reported adverse events (FAERS/openFDA)#

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