BIORESTORE HAND SANITIZING WIPES- ethyl alcohol cloth 
UNIVERSAL CONSUMER BRANDS INC

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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BIORESTORE- Hand Sanitizing wipes

Active Ingredient(s)

Ethanol Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Antiseptic skin cleanser, Kills harmful bacteria

Warnings

When using

When using this product keep out of eyes. If contact with eyes occurs, rinse thoroughly with water.

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

Do not use

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

Directions

Other information

Inactive ingredients

Water, Fragrance, Isopropyl alcohol, glycerin, denatonium benzoate

Package Label - Principal Display Panel

1

BIORESTORE HAND SANITIZING WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78489-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70   in 100 
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78489-003-8080 in 1 CONTAINER; Type 0: Not a Combination Product01/14/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/14/2021
Labeler - UNIVERSAL CONSUMER BRANDS INC (246799600)
Registrant - UNIVERSAL CONSUMER BRANDS INC (246799600)
Establishment
NameAddressID/FEIBusiness Operations
UNIVERSAL CONSUMER BRANDS INC246799600manufacture(78489-003)

Revised: 1/2021
Document Id: b8e681d3-34fd-0f64-e053-2995a90a5aea
Set id: b8e681c6-bf18-3eba-e053-2a95a90a1c6e
Version: 1
Effective Time: 20210114
 
UNIVERSAL CONSUMER BRANDS INC