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

Active Ingredient

Active Ingredient

Ethyl alcohol 65% 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, 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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable, keep away from fire or flame

Active Ingredient (55106-9)

Active Ingredient

Ethyl alcohol 65% 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)

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

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