SOAPBOX HAND SANITIZER ANTIMICROBIAL- alcohol gel

Soapbox Hand Sanitizer by

Drug Labeling and Warnings

Soapbox Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Soapbox Soaps, LLC, Garcoa, Inc., Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

• ⬥ Hand sanitizer to help reduce bacteria on the skin that could cause disease
• ⬥ Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts..

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• ⬥ place enough product in your palm to thoroughly cover your hands
• ⬥ Rub hands together briskly until dry.
• ⬥ Children under 6 years of age should be supervised when using this product.

Other information

• ⬥ Store at room temperature
• ⬥ May discolor certain fabrics or surfaces.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Citrus Limon (Lemon) Peel Oil, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Water

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY SOAPBOX SOAPS LLC | ALL RIGHTS RESERVED | WASHINGTON, D.C. 20007

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Sb®
SOAPBOX

HAND
SANITIZER

70% ALCOHOL
BASED FORMULA

HELPS REDUCE PATHOGENIC
GERMS ON HANDS

WITH MOISTURIZERS
& VITAMIN E

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

SOAPBOX HAND SANITIZER   ANTIMICROBIAL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75115-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
LEMON OIL (UNII: I9GRO824LL)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75115-306-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	06/25/2020

Labeler - Soapbox Soaps, LLC (034861706)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(75115-306)