BioTide Hand Sanitizer by Bioriginal Food & Science Corp BioTide Hand Sanitizer

Drug Details [pdf]

BIOTIDE HAND SANITIZER- alcohol liquid
Bioriginal Food & Science 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.

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BioTide Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 80% v/v (technical grade)

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

on children less than 2 months of age
on open skin wounds
if you are pregnant or breastfeeding

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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 Contr ol Center right away.

Do not inhale

Directions

Adults only
Place enough product on hands to cover all surfaces. Rub hands together until dry.

Other Information

Store between 15-30ºC (59-86ºF)
Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients:

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

Bottle

BIOTIDE HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76815-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76815-001-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	06/29/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/30/2020	06/29/2021

Labeler - Bioriginal Food & Science Corp (253686471)

Revised: 10/2021

Document Id: cf4209eb-5b4e-09ec-e053-2995a90a3b40

Set id: aa7d1105-f0c7-c4d7-e053-2995a90a8f58

Version: 2

Effective Time: 20211026