drug facts

drug facts

SPL v1

SPL

SPL Set ID a684b39d-3127-4f42-b188-fbcd55be398f

Route

topical

Published

Effective Date 2010-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (63 mL)

Inactive Ingredients

carbomer copolymer type a fd&c red no. 4 fd&c yellow no. 5 propylene glycol trolamine water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2010-08-01

Purpose

Antiseptic

Description

Ethyl Alcohol 63%

Medication Information

Warnings

For external use only
Flammable, keep away from fire and flame
Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

Uses

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Purpose

Antiseptic

Directions

Rub quarter sized amount between hands until dry
Supervise children in the use of this product

Other Information

Store below 105F
May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Red 4, FDC Yellow 5, Fragrance, Propylene Glycol, Triethanolamine, Water

Description

Ethyl Alcohol 63%

Package Label

Package Label

Active Ingredient

Ethyl Alcohol 63%

When Using This Product

avoid the eyes an mucous membranes
in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use and Ask A Doctor If

condition worsens
redness or irritation develops
if condition persists for more than 3 days

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center immediately.

Structured Label Content

Warnings

For external use only
Flammable, keep away from fire and flame
Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

Uses

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Purpose

Antiseptic

Directions

Rub quarter sized amount between hands until dry
Supervise children in the use of this product

Other Information (Other information)

Store below 105F
May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Red 4, FDC Yellow 5, Fragrance, Propylene Glycol, Triethanolamine, Water

Package Label

Package Label

Active Ingredient

Ethyl Alcohol 63%

When Using This Product (When using this product)

avoid the eyes an mucous membranes
in the case of eyes or mucous membrane contact; rinse area thoroughly with water

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

condition worsens
redness or irritation develops
if condition persists for more than 3 days

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

If swallowed contact a doctor or Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "63", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER COPOLYMER TYPE A", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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)

{"Uses": "For handwashing to decrease bacteria on the skin Recommended for repeated use", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable, keep away from fire and flame Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances", "Directions": "Rub quarter sized amount between hands until dry Supervise children in the use of this product", "Package Label": "Package Label", "Active Ingredient": "Ethyl Alcohol 63%", "Other information": "Store below 105F May discolor some fabrics", "Inactive Ingredients": "Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Red 4, FDC Yellow 5, Fragrance, Propylene Glycol, Triethanolamine, Water", "When using this product": "avoid the eyes an mucous membranes in the case of eyes or mucous membrane contact; rinse area thoroughly with water", "Stop use and ask a doctor if": "condition worsens redness or irritation develops if condition persists for more than 3 days", "Keep out of reach of children": "If swallowed contact a doctor or Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:06.468627 · Updated: 2026-03-14T22:52:26.166879