ADVANCED HAND SANITIZER- alcohol gel 
Biominerales Pharma, LLC

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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ADVANCED HAND SANITIZER

Drug facts

Active Ingredient (s)

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria on the skin when water and soap are not available.

WARNINGS

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

Do not use

  • Children under 6 years of a age should be supervise when using this product
  • On open skin wounds

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 for more than 72 hours, consult a doctor.

Keep out of reach of Children. If swallowed, get medical help or contact a Poison control center right away.

Directions

OTHER INFORMATION

Inactive Ingredients

glycerin, hydrogen, peroxide, purified water USP

PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label

BIOMINERALES
PHARMA

ADVANCED
HAND SANITIZER

Kills more than 99.99% of germs

Prevention:
Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
Keep container tightly closed.

Response:
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing. If eye
irritation persists: Get medical advice/ attention. In case of fire: Use
dry sand, dry chemical or alcohol-resistant foam for extinction.

Storage:
Store in a well-ventilated place. Keep cool.

Disposal:
Dispose of contents/ container to an approved waste disposal plant.

Active ingredients
Ethyl Alcohol 80%
Glycerin 1.45%
Hydrogen Peroxide .125%
Sterilized water 18.425%

Net Contents 3785 ML

Made in the USA

PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label
ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.0145 mL  in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.18425 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-100-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E05/10/2020
Labeler - Biominerales Pharma, LLC (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma, LLC117489663MANUFACTURE(77110-100)

Revised: 5/2020
Document Id: 175f8335-e49f-4031-bb57-0fcd244bf70b
Set id: 619d802c-ec12-4f59-b34c-c53a7c5c2a6d
Version: 1
Effective Time: 20200506
 
Biominerales Pharma, LLC