HAND SANITIZER- alcohol solution 
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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Hand Sanitizer

DRUG FACTS

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Inactive ingredients

Glycerin, Purified Water, Hydrogen Peroxide.

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

Distributed by:
MPP Dist. LLC.
sales@mppint.com

PRINCIPAL DISPLAY PANEL - 3.785 L Container Label

Alcohol Antiseptic 80% Topical Solution

MPP
INSTANT
HAND
SANITIZER

1 gallon
(3.785 L)

NDC: 77110-110-01

Distributed by:
MPP Dist. LLC.
sales@mppint.com

Kills 99.9% of Germs

PRINCIPAL DISPLAY PANEL - 3.785 L Container Label
HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-110-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/2020
Labeler - Biominerales Pharma (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma117489663MANUFACTURE(77110-110)

Revised: 7/2020
Document Id: 0cf8dfef-b3b7-46a8-b0f0-619ea97fc5ff
Set id: 6cb243a5-bffa-46d8-b44b-c7002cd2116a
Version: 2
Effective Time: 20200716
 
Biominerales Pharma