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

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 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

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

BIORESTORE HAND SANITIZING WIPES
ethyl alcohol cloth

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - UNIVERSAL CONSUMER BRANDS INC (246799600)

Registrant - UNIVERSAL CONSUMER BRANDS INC (246799600)

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