Biopure multipurpose wipes by QUEST USA CORP.

Biopure multipurpose wipes by

Drug Labeling and Warnings

Biopure multipurpose wipes by is a Otc medication manufactured, distributed, or labeled by QUEST USA CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOPURE MULTIPURPOSE WIPES- alcohol cloth 
QUEST USA CORP.

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.

----------

Active Ingredient

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Use

Apply topically as needed to cleanse.

Warnings

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

Do not use on

  • children less than 2 months old.
  • on open skin wounds.

When using this product do not get in eyes. If contact is made rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wipe area vigorously and discard.

Inactive ingredients

Purified water USP.

Product Label

image description

BIOPURE MULTIPURPOSE WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78691-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78691-010-0110 in 1 BAG06/20/202012/31/2022
130 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/20/202012/31/2022
Labeler - QUEST USA CORP. (079869689)
Establishment
NameAddressID/FEIBusiness Operations
SHANDONG HENGFA HYGIENIC PRODUCTS CO.,LTD546195384manufacture(78691-010)

Revised: 12/2022
Document Id: f0fb49be-2d21-319e-e053-2995a90aae39
Set id: 3c33be20-e36e-4979-9f5f-3b4402224e03
Version: 3
Effective Time: 20221229
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.