CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER- ethanol liquid

Clean Monster Lavender Peppermint Hand Sanitizer by

Drug Labeling and Warnings

Clean Monster Lavender Peppermint Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Clean Monster LLC, GPS Associates. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 70%

Purpose:

Antiseptic

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.

Do not use

• In children less than 2 months of age
• On open skin wounds

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. If swallowed, get medical help or contact the 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.

STORAGE AND HANDLING

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha piperita (Peppermint) Oil, Tocopherol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78723-001
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78723-001-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78723-001-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Clean Monster LLC (131398718)

Establishment
Name	Address	ID/FEI	Business Operations
GPS Associates		096942063	manufacture(78723-001)