Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ff0d4cfb-a3ba-430e-a2e0-1a080493403d

Route

TOPICAL

Published

Effective Date 2013-11-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (65 mL)

Inactive Ingredients

Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Peg-12 Dimethicone (300 Cst) Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-11-01

Description

Inactive Ingredients carbomer 940, Peg-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, 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 together briskly

until dry.

Description

Inactive Ingredients carbomer 940, Peg-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, water

Section 44425-7

Other Information.

Store below 110 F (43C)

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center

right away

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, Peg-12 dimethicone, propylene glycol,

tocopheryl acetate, triethanolamine, 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 together briskly

until dry.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other Information.

Store below 110 F (43C)

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 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, Peg-12 dimethicone, propylene glycol,

tocopheryl acetate, triethanolamine, 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": "PEG-12 DIMETHICONE (300 CST)", "unii": "ZEL54N6W95", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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 together briskly until dry.", "34071-1": "Warnings For external use only", "44425-7": "Other Information. Store below 110 F (43C)", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away", "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, Peg-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, 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: 2026-02-15T11:55:42.962880 · Updated: 2026-03-14T22:53:37.408704