FDA.reportPublic FDA data

Pro Clean Alcohol Wipes

Manufacturer
Shandong Oushile Biotechnology Co.Ltd
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
32656
Source
legacy-cache
Hydrated at
2026-08-01 23:19:23

Label at a glance#

ProductPro Clean Alcohol Wipes
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Open the package and wipe skin 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Ethyl Alcohol   Antiseptic

Use

INDICATIONS & USAGE SECTION

Helps reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age.
  • on open skin wounds.

When using this product

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Open the package and wipe skin 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)

Manufactured by Shandong Oushile Biotechnology Co.Ltd

SPL UNCLASSIFIED SECTION

Made in China

Distributed by Rixi Group USA, Inc
8966 Mason Ave, Chatsworth, CA 91311
Phone: (818)341-6600
gary@rixiglobal.net

Inactive ingredients

INACTIVE INGREDIENT SECTION

CETYLPYRIDINIUM CHLORIDE, WATER

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78781-08078781-080-50, 78781-080-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
WATER059QF0KO0RIACT

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
a643574d-def3-46be-b208-9e590a55068f654e4dba-9d99-4572-bbb4-e8be7960dd652020-08-04WarningsExact identifier
spl id: a643574d-def3-46be-b208-9e590a55068f
spl set id: 654e4dba-9d99-4572-bbb4-e8be7960dd65

Reported adverse events (FAERS/openFDA)#

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