HAND SANITIZING- isopropyl alcohol gel

HAND SANITIZING by

Drug Labeling and Warnings

HAND SANITIZING by is a Otc medication manufactured, distributed, or labeled by Biominerales Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• - 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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HAND SANITIZING 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77110-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302)	Isopropyl alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
Propylene Glycol (UNII: 6DC9Q167V3)
Trolamine (UNII: 9O3K93S3TK)
Hydrogen Peroxide (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77110-600-04	236 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020
2	NDC: 77110-600-03	473 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020
3	NDC: 77110-600-02	946 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020
4	NDC: 77110-600-01	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	09/01/2020

Labeler - Biominerales Pharma (117489663)

Establishment
Name	Address	ID/FEI	Business Operations
Biominerales Pharma		117489663	MANUFACTURE(77110-600)