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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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.

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).

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

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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.

Manufactured by:
Hempire Farms, LLC
150 E Palmetto Park Rd
Boca Raton, FL 33432

PRINCIPAL DISPLAY PANEL - 473 mL Container Label

USA
HEMPIRE
FARMS

MADE IN
USA

KILLS HARMFUL BACTERIA/GERMS

16 fl. Oz. (473 mL)

HAND SANITIZING GEL with
HEMP OIL & ALOE for moisturizing

16 fl. oz.
(473 mL)

70 %
v/v
ADVANCED

ISOPROPYL
ALCOHOL
PROTECTION

PRINCIPAL DISPLAY PANEL - 473 mL Container Label
HAND SANITIZING 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-600
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:77110-600-04236 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
2NDC:77110-600-03473 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
3NDC:77110-600-02946 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
4NDC:77110-600-013785 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(77110-600)

Revised: 9/2020
Document Id: bc321917-986d-4a5e-b779-86cb7171090d
Set id: 2ff3d532-1dee-4cfb-8852-20f654fb8b61
Version: 1
Effective Time: 20200902
 
Biominerales Pharma