Shandong Oushile Biotechnology Co.Ltd

Pro Clean Alcohol Wipes by

Drug Labeling and Warnings

Pro Clean Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Shandong Oushile Biotechnology Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRO CLEAN ALCOHOL WIPES- alcohol wipes cloth 
Shandong Oushile Biotechnology Co.Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Shandong Oushile Biotechnology Co.Ltd

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Ethyl Alcohol   Antiseptic

Use

Helps reduce bacteria that potentially can cause disease.

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

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.

Directions

  • Open the package and wipe skin until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Manufactured by Shandong Oushile Biotechnology Co.Ltd

Made in China

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

Inactive ingredients

CETYLPYRIDINIUM CHLORIDE, WATER

Package Label - Principal Display Panel

image description

image description

PRO CLEAN ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78781-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78781-080-5050 in 1 PACKAGE; Type 0: Not a Combination Product08/03/2020
2NDC: 78781-080-75175 in 1 PACKAGE; Type 0: Not a Combination Product08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/202008/05/2020
Labeler - Shandong Oushile Biotechnology Co.Ltd (554531936)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Oushile Biotechnology Co.Ltd554531936manufacture(78781-080)

Revised: 8/2020
Document Id: a643574d-def3-46be-b208-9e590a55068f
Set id: 654e4dba-9d99-4572-bbb4-e8be7960dd65
Version: 32656
Effective Time: 20200804