MEDICAL GRADE HAND SANITIZER- alcohol gel 
Biominerales Pharma

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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MEDICAL GRADE HAND SANITIZER

DRUG FACTS

Active ingredient

Ethyl alcohol (70% v/v)

Purpose

Antiseptic

Inactive ingredients

Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate, Purified Water, Fragrance.

Use (s)

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

Warnings

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

Do not use in children less than 2 months of age or on open skin wounds.

When using this product keep our 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 poison control center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

ADVANCED PROTECTION
KILLS VIRUSES AND GERMS

SCIENTIFIC
SOLUTIONS

MEDICAL GRADE GEL HAND SANITIZER

70% ALCOHOL

(236ml/8oz)

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
MEDICAL GRADE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-500-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
2NDC:77110-500-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
3NDC:77110-500-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E07/20/2020
Labeler - Biominerales Pharma (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma117489663MANUFACTURE(77110-500)

Revised: 7/2020
Document Id: 72b1bb45-de73-44ff-bfd4-4766b83f9b70
Set id: 5f5c14ff-41c4-44d9-b0ce-80acf9faa208
Version: 1
Effective Time: 20200720
 
Biominerales Pharma