DRUG FACTS

Active ingredient[s]

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Use[s]

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. 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

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 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

Water (Aqua), Polyquaternium-37, Glycerin, Panthenol, Niacinamide, Polysorbate 20, Tocopheryl Acetate, Benzalkonium Chloride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Propylene Glycol, Benzyl Alcohol, Methlchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow 5 (CI 19140).

Questions or comments

1-877-847-0060 / info@dewmed.group

Package Labeling:

Bottle

DEWMED ANTIBACTERIAL ADVANCED HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80065-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80065-000-01	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/20/2020

Labeler - DewMed, LLC (117608946)

DewMed Antibacterial Advanced Hand Gel Sanitizer