ADVANCED PROTECTION HAND SANITIZING- isopropyl 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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ADVANCED PROTECTION HAND SANITIZING

DRUG FACTS

Active ingredients

Isopropyl alcohol – 70% v/v

Purpose

Antiseptic

Inactive ingredients

Deionized water, Carbomer, Propylene Glycol, Triethanolamine,Hydrogen Peroxide.

Use (s)

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

Cautions and warnings

- For external use only

- Flammable

- Keep away from heat or flame

- Keep out of reach of children

- 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

- 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.

Stop use and ask a doctor if irritation or rash occurs

Directions

Rub thoroughly into hands for at least 30 seconds, allow to dry.

Supervise children when they use this product.

Adults and children 2 years and older:

For occasional and personal domestic use.

Other information

Store Between 15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above 40 °C (104 °F).

Manufactured by:
Biominerales Pharma, LLC
150 E Palmetto Park Rd
Boca Raton, FL 33432

PRINCIPAL DISPLAY PANEL - 3,785 ml Container Label

ADVANCED PROTECTION
HAND SANITIZING GEL

BIOMINERALES PHARMA

KILLS HARMFUL BACTERIA/GERMS

1 Gallon
(3,785ml)

70%
v/v
ISOPROPYL
ALCOHOL

PRINCIPAL DISPLAY PANEL - 3,785 ml Container Label
ADVANCED PROTECTION HAND SANITIZING 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Trolamine (UNII: 9O3K93S3TK)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77110-700-04236 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
2NDC:77110-700-03473 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
3NDC:77110-700-02946 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
4NDC:77110-700-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E09/01/2020
Labeler - Biominerales Pharma (117489663)
Establishment
NameAddressID/FEIBusiness Operations
Biominerales Pharma117489663MANUFACTURE(77110-700)

Revised: 8/2020
Document Id: 31903ba4-da68-4199-acdc-a9c5b5c65f81
Set id: 1ca52f6e-106d-4c1f-93fe-7448aff6a4dd
Version: 1
Effective Time: 20200831
 
Biominerales Pharma