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 (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 potentiallycan 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.

PRINCIPAL DISPLAY PANEL - 2 FL Oz. Bottle Label

Alcohol Antiseptic 70%
Topical Solution

MPP
INSTANT
HAND
SANITIZER

Hand Sanitizer
Non-Sterile Solution
2 FL Oz.

Kills 99.9% of Germs

PRINCIPAL DISPLAY PANEL - 2 FL Oz. Bottle Label
HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-210
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:77110-210-0659 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
2NDC:77110-210-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
3NDC:77110-210-02944 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
4NDC:77110-210-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
5NDC:77110-210-04236 mL in 1 BOTTLE; 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(77110-210)

Revised: 7/2020
Document Id: e0fcc752-704d-4438-9391-adbbebe1fb43
Set id: 05fc524e-7ee9-4096-a5a7-57f426a992ca
Version: 3
Effective Time: 20200727
 
Biominerales Pharma