BioTide Antiseptic Hand Sanitizer Gel

BioTide Antiseptic Hand Sanitizer Gel by

Drug Labeling and Warnings

BioTide Antiseptic Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Bioriginal Food & Science Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOTIDE ANTISEPTIC HAND SANITIZER GEL- alcohol gel 
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 Antiseptic Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

  • For external use only.
  • Flammable, keep away from fire or flame.

Do not use 

in the eyes

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

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

Inactive ingredients

Purified water, glycerin, carbomer 940, d-alpha tocopherol acetate, fragrance, glitter (rayon, glycerin, water, urea, shellac, mica, titanium dioxide, ferric ammonium ferrocyanide, tin oxide), triethanolamine.

Questions or Comments?

949-622-9030

Package Labeling:

Bottle

BIOTIDE ANTISEPTIC HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76815-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
REGENERATED CELLULOSE (UNII: BX81F82EWG)  
UREA (UNII: 8W8T17847W)  
SHELLAC (UNII: 46N107B71O)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76815-002-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/202006/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/01/202006/29/2021
Labeler - Bioriginal Food & Science Corp (253686471)

Revised: 10/2021
Document Id: cf35bf38-069e-174c-e053-2995a90acf80
Set id: b25cc7df-9b97-35fa-e053-2a95a90a1795
Version: 2
Effective Time: 20211025