Drug Facts 62654-140

SPL v3

SPL

SPL Set ID 36783d30-a222-40fe-a5ea-61a2842a34c9

Route

TOPICAL

Published

Effective Date 2011-06-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (64.5 mL)

Inactive Ingredients

Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Edetic Acid Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2001-01-01

Description

Active Ingredients Ethanol 64.5% (w/w)

Medication Information

Warnings and Precautions

Warnings

For External Use Only

Flammable, keep away from fire or flame

Indications and Usage

Uses

An antiseptic hand sanitizer for topical application

Prevents infection and cross contamination

Reduces transient microorganisms on intact skin

Keep hands from drying due to repeated uses

Dosage and Administration

Directions

Wet hands thoroughly with product.

Allow to dry without wiping.

Use no water or towels.

Description

Active Ingredients Ethanol 64.5% (w/w)

Section 50565-1

Keep out of reach of children.

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

Section 50567-7

When using this product

Avoid contact with eyes

In case of eye contact, flush with water for 15 minutes

Discontinue use and see a doctor if irritation occurs

Avoid contact with broken skin

Section 51727-6

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water

Section 51945-4

DermaCen

Instant

Hand Sanitizer

For hand washing to decrease bacteria on the skin.

Net Contents 8 ounces (236 ml)

Section 54433-8

Other Information

This product has not been tested on animals.

Section 55105-1

Purpose

Hand Sanitizer

Section 55106-9

Active Ingredients

Ethanol 64.5% (w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses

An antiseptic hand sanitizer for topical application

Prevents infection and cross contamination

Reduces transient microorganisms on intact skin

Keep hands from drying due to repeated uses

Dosage and Administration (34068-7)

Directions

Wet hands thoroughly with product.

Allow to dry without wiping.

Use no water or towels.

Warnings and Precautions (34071-1)

Warnings

For External Use Only

Flammable, keep away from fire or flame

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 50567-7 (50567-7)

When using this product

Avoid contact with eyes

In case of eye contact, flush with water for 15 minutes

Discontinue use and see a doctor if irritation occurs

Avoid contact with broken skin

Section 51727-6 (51727-6)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water

Section 51945-4 (51945-4)

DermaCen

Instant

Hand Sanitizer

For hand washing to decrease bacteria on the skin.

Net Contents 8 ounces (236 ml)

Section 54433-8 (54433-8)

Other Information

This product has not been tested on animals.

Section 55105-1 (55105-1)

Purpose

Hand Sanitizer

Section 55106-9 (55106-9)

Active Ingredients

Ethanol 64.5% (w/w)

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "64.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses An antiseptic hand sanitizer for topical application Prevents infection and cross contamination Reduces transient microorganisms on intact skin Keep hands from drying due to repeated uses", "34068-7": "Directions Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels.", "34071-1": "Warnings For External Use Only Flammable, keep away from fire or flame", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product Avoid contact with eyes In case of eye contact, flush with water for 15 minutes Discontinue use and see a doctor if irritation occurs Avoid contact with broken skin", "51727-6": "Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water", "51945-4": "DermaCen Instant Hand Sanitizer For hand washing to decrease bacteria on the skin. Net Contents 8 ounces (236 ml)", "54433-8": "Other Information This product has not been tested on animals.", "55105-1": "Purpose Hand Sanitizer", "55106-9": "Active Ingredients Ethanol 64.5% (w/w)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.759957 · Updated: 2026-03-14T23:05:34.774689