Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 2db610b9-9e10-08ad-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2016-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 g)

Inactive Ingredients

Trolamine Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Fd&c Yellow No. 5 Water Fd&c Blue No. 1 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-03-04

Description

Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Uses

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

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

Package Label

Active Ingredient

Alcohol 62%

Other Information

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FD&C Blue 1, FD&C Yellow 5, Fragrance (parfume), Hydrogenated Castor Oil, PEG-40, Triethanolamine, Water

When Using This Product

■ Avoid the eyes and 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

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 & 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

Package Label

Active Ingredient

Alcohol 62%

Other Information (Other information)

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FD&C Blue 1, FD&C Yellow 5, Fragrance (parfume), Hydrogenated Castor Oil, PEG-40, Triethanolamine, Water

When Using This Product (When using this product)

■ Avoid the eyes and 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": "TROLAMINE", "unii": "9O3K93S3TK", "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 YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED CASTOR OIL", "unii": "ZF94AP8MEY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

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 & 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", "Active Ingredient": "Alcohol 62%", "Other information": "■ Store below 105°F ■ May discolor some fabrics", "Inactive Ingredients": "Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FD&C Blue 1, FD&C Yellow 5, Fragrance (parfume), Hydrogenated Castor Oil, PEG-40, Triethanolamine, Water", "When using this product": "■ Avoid the eyes and 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: 2026-02-15T11:56:27.234738 · Updated: 2026-03-14T22:54:56.160161