drug facts

drug facts

SPL v1

SPL

SPL Set ID dc39d110-9bb1-4053-a490-f5713701864e

Route

topical

Published

Effective Date 2013-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (68 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 2013-07-01

Description

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

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active Ingredient

Ethyl Alcohol 68% v/v

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 60561-8

Flammable. Keep away

from fire or flame

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active Ingredient

Ethyl Alcohol 68% v/v

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.

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 60561-8 (60561-8)

Flammable. Keep away

from fire or flame

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "68", "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 68% v/v", "60561-8": "Flammable. Keep away from fire or flame"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:39.349404 · Updated: 2026-03-14T22:53:32.152302