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SPL v1

SPL

SPL Set ID a9da14a5-1923-4289-e053-2995a90a03e8

Route

topical

Published

Effective Date 2020-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (62 mL)

Inactive Ingredients

glycerin carbomer homopolymer, unspecified type water denatonium benzoate aminomethylpropanol fd&c red no. 40

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-07-01

Purpose

Antiseptic

Description

Alcohol 62%

Medication Information

Warnings

■ For external use only

■ Flammable, keep away from fire & flame

■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

Purpose

Antiseptic

Directions

■ Rub dime sized amount between hands until dry

■ Supervise children in the use of this product

■ In the case of eye contact, rinse eyes thoroughly with water

Other Information

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Denatonium Benzoate, Red 40

Description

Alcohol 62%

Questions?

■ 1-800-278-9218

Use

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

Active Ingredient

Alcohol 62%

Package Label Pink

When Using This Product

■ Avoid the eyes and mucous membranes

■ In the case of eyes or mucous membranes 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 & flame

■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances

Purpose

Antiseptic

Directions

■ Rub dime sized amount between hands until dry

■ Supervise children in the use of this product

■ In the case of eye contact, rinse eyes thoroughly with water

Other Information (Other information)

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Denatonium Benzoate, Red 40

Questions?

■ 1-800-278-9218

Use

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

Active Ingredient

Alcohol 62%

Package Label Pink

When Using This Product (When using this product)

■ Avoid the eyes and mucous membranes

■ In the case of eyes or mucous membranes 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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use", "Purpose": "Antiseptic", "Warnings": "■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances", "Directions": "■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water", "Questions?": "■ 1-800-278-9218", "Active Ingredient": "Alcohol 62%", "Other information": "■ Store below 105°F ■ May discolor some fabrics", "Inactive Ingredients": "Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Denatonium Benzoate, Red 40", "When using this product": "■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membranes 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: 2026-02-15T11:58:08.340554 · Updated: 2026-03-14T22:57:33.152130