Antibacterial

SPL v6

SPL

SPL Set ID cd9646e3-3ac6-47c3-bee0-ea1d40153475

Route

TOPICAL

Published

Effective Date 2011-12-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (620 g)

Inactive Ingredients

2-ethylaminoethanol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Glycerin Propylene Glycol Water

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-09-01

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Use(s)

To decrease bacteria on skin

Storage

Do not store above 105F (40C)

Directions

Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.

Active Ingredient

Ethyl Alcohol 62%

Inactive Ingredients

Amino Methyl Propanol, Carbomer, FD&C Blue #1, Fragrance, Propylene Glycol, Purified Water

For External Use Only

Flammable! Keep away from fire or flame. Do not use in eye; if this happens rinse thoroughly with water.

Principal Display Panel

Antibacterial Gel Labels

Stop Use and Ask A Doctor If

irritation or redness develops and persists more than 72 hours

Keep Out of Reach of Children

If ingested get medical help or contact a Poison Control Center right away

Structured Label Content

Use(s)

To decrease bacteria on skin

Purpose

Antiseptic

Storage

Do not store above 105F (40C)

Directions

Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.

Active Ingredient (Active ingredient)

Ethyl Alcohol 62%

Inactive Ingredients (Inactive ingredients)

Amino Methyl Propanol, Carbomer, FD&C Blue #1, Fragrance, Propylene Glycol, Purified Water

For External Use Only (For external use only)

Flammable! Keep away from fire or flame. Do not use in eye; if this happens rinse thoroughly with water.

Principal Display Panel

Antibacterial Gel Labels

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or redness develops and persists more than 72 hours

Keep Out of Reach of Children (Keep out of reach of children)

If ingested get medical help or contact a Poison Control Center right away

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "620", "strengthDenominator": "1.0", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "kg"}, {"name": "2-ETHYLAMINOETHANOL", "unii": "1G0G2TK41H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": " To decrease bacteria on skin", "Purpose": " Antiseptic", "Storage": " Do not store above 105F (40C)", "Directions": " Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.", "Active ingredient": " Ethyl Alcohol 62%", "Inactive ingredients": " Amino Methyl Propanol, Carbomer, FD&C Blue #1, Fragrance, Propylene Glycol, Purified Water", "For external use only": " Flammable! Keep away from fire or flame. Do not use in eye; if this happens rinse thoroughly with water.", "Principal Display Panel": " Antibacterial Gel Labels", "Stop use and ask a doctor if": " irritation or redness develops and persists more than 72 hours", "Keep out of reach of children": "If ingested get medical help or contact a Poison Control Center right away "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.256346 · Updated: 2026-03-14T22:53:10.919261