BIORESTORE HAND SANITIZING WIPES- ethyl alcohol cloth

BioRestore Hand Sanitizing Wipes by

Drug Labeling and Warnings

BioRestore Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by UNIVERSAL CONSUMER BRANDS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethanol Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Antiseptic skin cleanser, Kills harmful bacteria

Warnings

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

When using

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

STOP USE

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

Do not use

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Wipe thoroughly into hands for atleast 30 seconds. Allow to dry.
• Children under 6 years of age should be supervised when using product.

Other information

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

Inactive ingredients

Water, Fragrance, Isopropyl alcohol, glycerin, denatonium benzoate

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BIORESTORE HAND SANITIZING WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78489-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70   in 100

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78489-003-80	80 in 1 CONTAINER; Type 0: Not a Combination Product	01/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2021

Labeler - UNIVERSAL CONSUMER BRANDS INC (246799600)

Registrant - UNIVERSAL CONSUMER BRANDS INC (246799600)

Establishment
Name	Address	ID/FEI	Business Operations
UNIVERSAL CONSUMER BRANDS INC		246799600	manufacture(78489-003)