Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID b833cb94-cc8f-42af-ba79-01c81b53be23

Route

TOPICAL

Published

Effective Date 2014-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (65 mL)

Inactive Ingredients

Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Glycerin Propylene Glycol D&c Red No. 33 .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-09-01

Description

Inactive Ingredients carbomer 940, glycerin, propylene glycol, red 33, tocopheryl acetate, triethonamoline, water

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses. hand sanitizer to help

reduce bacteria on skin

Dosage and Administration

Directions. Put a dime sized

drop onto hands and rub

briskly until dry.

Description

Inactive Ingredients carbomer 940, glycerin, propylene glycol, red 33, tocopheryl acetate, triethonamoline, water

Section 44425-7

Other information

Store below 110 F ( 43 C)

Section 50565-1

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Section 50566-9

Stop use and ask a doctor

if irritation, excessive redness

or rash develops

Section 50570-1

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Section 51727-6

Inactive Ingredients

carbomer 940, glycerin,

propylene glycol, red 33,

tocopheryl acetate,

triethonamoline, water

Section 51945-4

Section 55105-1

Purpose Antimicrobial

Section 55106-9

Active Ingredient

Ethyl Alcohol, 65 % v/v

Section 60561-8

Flammable. Keep away from

fire or flame

Structured Label Content

Indications and Usage (34067-9)

Uses. hand sanitizer to help

reduce bacteria on skin

Dosage and Administration (34068-7)

Directions. Put a dime sized

drop onto hands and rub

briskly until dry.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

Store below 110 F ( 43 C)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor

if irritation, excessive redness

or rash develops

Section 50570-1 (50570-1)

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients

carbomer 940, glycerin,

propylene glycol, red 33,

tocopheryl acetate,

triethonamoline, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol, 65 % v/v

Section 60561-8 (60561-8)

Flammable. Keep away from

fire or flame

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "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": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses. hand sanitizer to help reduce bacteria on skin", "34068-7": "Directions. Put a dime sized drop onto hands and rub briskly until dry.", "34071-1": "Warnings For external use only", "44425-7": "Other information Store below 110 F ( 43 C)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation, excessive redness or rash develops", "50570-1": "Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "51727-6": "Inactive Ingredients carbomer 940, glycerin, propylene glycol, red 33, tocopheryl acetate, triethonamoline, water", "55105-1": "Purpose Antimicrobial", "55106-9": "Active Ingredient Ethyl Alcohol, 65 % v/v", "60561-8": "Flammable. Keep away from fire or flame"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:50.015666 · Updated: 2026-03-14T22:53:48.902596