28 MILE FOOLS GIN HAND SANITIZER- alcohol gel

28 Mile Fools Gin Hand Sanitizer by

Drug Labeling and Warnings

28 Mile Fools Gin Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by 28 MILE DISTILLING COMPANY, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 80% v/v.

Purpose

Hand Sanitizer

Uses

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

Warnings

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, Polyethylene glycol, Acrylate polymer.

SPL UNCLASSIFIED SECTION

For External Use Only Do Not Drink

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

28 MILE FOOLS GIN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
1,2,3-PROPANETRIOL, 2-(4-AMINOBENZOATE) (UNII: 3S4077U0T0)
LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)
.ALPHA.-PINENE (UNII: JPF3YI7O34)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
LEMON OIL (UNII: I9GRO824LL)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
CORIANDER OIL (UNII: 7626GC95E5)
ORANGE OIL (UNII: AKN3KSD11B)
CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)
CITRONELLA OIL (UNII: QYO8Q067D0)
CITRONELLOL ACETATE, (R)- (UNII: 9X45FJL446)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MANDARIN OIL (UNII: NJO720F72R)
LIME OIL (UNII: UZH29XGA8G)
CAMPHOR OIL (UNII: 75IZZ8Y727)
CYCLOHEXANONE (UNII: 5QOR3YM052)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020
2	NDC: 77340-001-02	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020
3	NDC: 77340-001-03	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020
4	NDC: 77340-001-04	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

Labeler - 28 MILE DISTILLING COMPANY, LLC (107153056)

Establishment
Name	Address	ID/FEI	Business Operations
28 MILE DISTILLING COMPANY, LLC		107153056	manufacture(77340-001)