Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 4ca21370-1ecf-42c6-9c32-79cf994c336b

Route

TOPICAL

Published

Effective Date 2025-03-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Water Edetate Sodium Cocamidopropyl Betaine Peg-7 Glyceryl Cocoate Propylene Glycol Phenoxyethanol Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2016-05-31 Until 2026-11-18

Description

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial Agent

Medication Information

Purpose

Antibacterial Agent

Description

Benzalkonium Chloride 0.13% w/w

Uses

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

Section 50565-1

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1

Avoid contact with eyes

Section 51727-6

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

Warnings

For external use only

Directions

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

Active Ingredient

Benzalkonium Chloride 0.13% w/w

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

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Avoid contact with eyes

Section 51727-6 (51727-6)

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

Purpose

Antibacterial Agent

Warnings

For external use only

Directions

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

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Representative Label and Principal Display Panel (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

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-7 GLYCERYL COCOATE", "unii": "VNX7251543", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.", "50565-1": "Keep out of reach of children. If swallowed, contact a physician or poison control center.", "50567-7": "Avoid contact with eyes. If contact occurs, flush with water.", "50569-3": "Stop use if , in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.", "50570-1": "Avoid contact with eyes", "51727-6": "Inactive Ingredients Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.", "Purpose": "Antibacterial Agent", "Warnings": "For external use only", "Directions": "To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.", "Active Ingredient": "Benzalkonium Chloride 0.13% w/w", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:39.935447 · Updated: 2026-03-14T23:07:49.806657