Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 042ceb6e-ce5f-4b1f-b947-16829e3e7a43

Route

TOPICAL

Published

Effective Date 2025-01-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Glycerin Propylene Glycol Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate Carbomer 1342 Aminomethylpropanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2009-01-02 Until 2026-07-09

Description

Ethyl Alcohol 62% v/v

Purpose

Antibacterial Agent

Medication Information

Purpose

Antibacterial Agent

Description

Ethyl Alcohol 62% v/v

Uses

For handwashing to decrease bacteria on skin.

Section 50565-1

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

Section 50567-7

Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.

Section 50569-3

Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.

Section 50570-1

Do not use in Eyes

Warnings

For external use only

Flammable Keep away from heat or flame.

Directions

To decrease bacterial on skin, apply a small amount to palm. Briskly rub, covering hands withproduct until dry.

Active Ingredient

Ethyl Alcohol 62% v/v

Inactive Ingredients

Water, glycerin, propylene glycol, isopropyl myristate, aloe barbadensis leaf, tocopheryl acetate (Vitamin E), Carbomer, Aminomethyl propanol.

Principal Display Panel and Representative Label

DELIVERING QUALITY SINCE 1906

BEN E.

KEITH

CO.

FOODSERVICE DISTRIBUTORS

GEL INSTANT HAND SANITIZER

Net Contents: 8 Fl. Oz. (237 mL)

Distributed by:

BEN E. KEITH FOODS Fort Worth, TX 76101

MADE IN USA

Structured Label Content

Uses

For handwashing to decrease bacteria on skin.

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)

Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.

Section 50569-3 (50569-3)

Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.

Section 50570-1 (50570-1)

Do not use in Eyes

Purpose

Antibacterial Agent

Warnings

For external use only

Flammable Keep away from heat or flame.

Directions

To decrease bacterial on skin, apply a small amount to palm. Briskly rub, covering hands withproduct until dry.

Active Ingredient

Ethyl Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene glycol, isopropyl myristate, aloe barbadensis leaf, tocopheryl acetate (Vitamin E), Carbomer, Aminomethyl propanol.

Principal Display Panel and Representative Label (Principal Display Panel and representative label)

DELIVERING QUALITY SINCE 1906

BEN E.

KEITH

CO.

FOODSERVICE DISTRIBUTORS

GEL INSTANT HAND SANITIZER

Net Contents: 8 Fl. Oz. (237 mL)

Distributed by:

BEN E. KEITH FOODS Fort Worth, TX 76101

MADE IN USA

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 1342", "unii": "809Y72KV36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For handwashing to decrease bacteria on skin.", "50565-1": "Keep out of reach of children. If swallowed, contact a physician or poison control center.", "50567-7": "Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.", "50569-3": "Stop use if redness and irritation develop. If condition persists for more than 72 hours, consult a physician.", "50570-1": "Do not use in Eyes", "Purpose": "Antibacterial Agent", "Warnings": "For external use only Flammable Keep away from heat or flame.", "Directions": "To decrease bacterial on skin, apply a small amount to palm. Briskly rub, covering hands withproduct until dry.", "Active Ingredient": "Ethyl Alcohol 62% v/v", "Inactive ingredients": "Water, glycerin, propylene glycol, isopropyl myristate, aloe barbadensis leaf, tocopheryl acetate (Vitamin E), Carbomer, Aminomethyl propanol.", "Principal Display Panel and representative label": "DELIVERING QUALITY SINCE 1906 BEN E. KEITH CO. FOODSERVICE DISTRIBUTORS GEL INSTANT HAND SANITIZER Net Contents: 8 Fl. Oz. (237 mL) Distributed by: BEN E. KEITH FOODS Fort Worth, TX 76101 MADE IN USA"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:24.956553 · Updated: 2026-03-14T23:07:10.032470