Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID e1a313a9-0b9d-4e02-aaa1-cb27e73d2101

Route

TOPICAL

Published

Effective Date 2013-04-13

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 Peg-12 Dimethicone (300 Cst) Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-05-01

Description

Inactive Ingredients carbomer, fragrance, glycerin, PEG-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, water

Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable, keep away from fire or flame

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, fragrance, glycerin, PEG-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, water

Section 44425-7

Enter section text here 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 50569-3

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, fragrance, glycerin, 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

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

Flammable, keep away from fire or flame

Section 44425-7 (44425-7)

Enter section text here 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 50569-3 (50569-3)

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, fragrance, glycerin, 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

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": "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 Flammable, keep away from fire or flame", "44425-7": "Enter section text here 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", "50569-3": "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, fragrance, glycerin, PEG-12 dimethicone, propylene glycol, tocopheryl acetate, triethanolamine, water", "55105-1": "Purpose Antimicrobial", "55106-9": " Active Ingredient Ethyl alcohol 65% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.277983 · Updated: 2026-03-14T22:53:28.900881