BEN E. KEITH FIHS- benzalkonium chloride solution

Ben E. Keith FIHS by

Drug Labeling and Warnings

Ben E. Keith FIHS by is a Otc medication manufactured, distributed, or labeled by Ben E. Keith Foods. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial Agent

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

• For external use only

• Avoid contact with eyes

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

• To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

INACTIVE INGREDIENT

Inactive Ingredients Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA.

Representative label and principal display panel

ALCOHOL-FREE

BEN E. KEITH

ESSENTIALS

FOAMINIG

INSTANT HAND

SANITIZER

REORDER

#885610

Net Contents: 1000 mL (33.8 Fl. Oz.)

DISTRIBUTED BY Ben E. Keith Foods

FT. WORTH, TX 76101

INGREDIENTS AND APPEARANCE

BEN E. KEITH FIHS 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50980-207
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50980-207-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/31/2016

Labeler - Ben E. Keith Foods (007929748)