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 0.13%

Uses

Effective in destroying harmful bacteria. Do not use on DivaCup.

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.

Inactive ingredients

Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Glycerin, Citric acid, Tetrasodium EDTA, Methylchloroisothiazolinone and Methylisothiazolinone, CI 19140, CI 42090, Parfum.

Package Label - Principal Display Panel

Label 1 Label 2

DIVAPROTECT HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77116-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77116-002-01	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/25/2020

Labeler - Diva International Inc. (207651758)