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NDC 50980-0207-12 Ben E. Keith FIHS 1.3 mg/mL Details

Ben E. Keith FIHS 1.3 mg/mL

Ben E. Keith FIHS is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ben E. Keith Foods. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	50980-0207
Product ID	50980-207_2e833f78-5ede-4e76-a1c7-6523cd419411
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ben E. Keith FIHS
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Ben E. Keith Foods
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50980-0207-12 (50980020712)

Pricing Information	N/A
NDC Package Code	50980-207-12
Billing NDC	50980020712
Package	1000 mL in 1 BAG (50980-207-12)
Marketing Start Date	2016-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4ca21370-1ecf-42c6-9c32-79cf994c336b Details

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.

SPL UNCLASSIFIED SECTION

Inactive Ingredients Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, 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

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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50980-207-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2016

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

Labeler - Ben E. Keith Foods (007929748)

Revised: 6/2022

Document Id: 2e833f78-5ede-4e76-a1c7-6523cd419411

Set id: 4ca21370-1ecf-42c6-9c32-79cf994c336b

Version: 3

Effective Time: 20220603