DIVAPROTECT HAND SANITIZER- benzalkonium chloride liquid
Diva International Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Benzalkonium Chloride 0.10%

Uses

Effective in destroying harmful bacteria, while moisturizing hands.

Warnings

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 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.

Inactive ingredients

Aqua/Water, Glyceryl Stearate (and) PEG-100 Stearate, Olea Europaea (Olive) Fruit Oil, Caprylic/Capric Triglycerides, Glycerin, Cetyl alcohol, Olea Europaea (Olive) Oil, Sodium Polyacrylate (and) C13-14 Isoparaffin (and) Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Butylated Hydrxytoluene, Lavandula Angustifolia, Matricaria Recutita (Chamomile) Extract, Silk Amino Acids, Panthenol

Package Label - Principal Display Panel

Label 1 Label 2

Label 3

DIVAPROTECT HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77116-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALLANTOIN (UNII: 344S277G0Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BENTONITE (UNII: A3N5ZCN45C)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77116-001-01	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/01/2020

Labeler - Diva International Inc. (207651758)