OPTIMAL RESULTS HAND SANITIZER- alcohol gel

Optimal Results Hand Sanitizer by

Drug Labeling and Warnings

Optimal Results Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HB Media LLC (dba Optimal Results), Fresh & Beautiful Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70%.

Purpose

Antibacterial

Use

For rinse-free hand sanitizing to remove 99.9% bacteria on skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105°F

Inactive Ingredients

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Principal Display Panel – Bottle Label

MADE IN U.S.A.

HAND SANITIZER

KILLS 99.9% OF GERMS ON CONTACT

OPTIMAL RESULTS

ALCOHOL 70% TOPICAL GEL SOLUTION

• ANTI-BACTERIAL
• ANTI-VIRAL
• CLEAN SCENT
• WITH ALOE

8 Fl Oz (240 mL)

INGREDIENTS AND APPEARANCE

OPTIMAL RESULTS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78956-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyl Acrylate/Methyl Methacrylate/Methacrylic Acid Copolymer (18000 MW) (UNII: JZ1374NL9E)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Aminomethylpropanol (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78956-101-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
2	NDC: 78956-101-02	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
3	NDC: 78956-101-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
4	NDC: 78956-101-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
5	NDC: 78956-101-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - HB Media LLC (dba Optimal Results) (117547515)

Establishment
Name	Address	ID/FEI	Business Operations
Fresh & Beautiful Cosmetics		117409349	MANUFACTURE(78956-101)