Cuticura- Antibacterial Hand Soap with Moisturizer & Pro-Vitamin B5

BENZALKONIUM CHLORIDE- antibacterial hand soap liquid
Brands International Corporation

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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Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Use for handwashing to decrease bacteria on the skin

Warning - For external use only - hands only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritaion or redness develops
condition persists for more than 72 hours

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

Directions

Wet Hands
Apply palmful to hands
scrub thoroughly
rinse thoroughly

Inactive Ingredients: Water (Aqua),Acrylates/C10-30 Alkyl Acrylate crosspolymer, Citrtic Acid, Cocamidopropyl Betaine,Cocamide MEA,Decyl Glucoside, DMDM Hydantoin,Sodium Benzoate, Sodium Laureth Sulfate, Sodium Chloride, Sodium Hydroxide, Glycerin, Fragrance,Panthenol (Parfum),PEG-12 Methyl Glucose Dioleate, Polyquatenium 10, Tetrasodium EDTA, Blue 1, Red# 4 (Cl 14700)

Cuticura

BENZALKONIUM CHLORIDE
antibacterial hand soap liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-210
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)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-210-01	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/30/2018

Labeler - Brands International Corporation (243748238)