drug facts

drug facts

SPL v1

SPL

SPL Set ID 407fef20-22fa-07de-e054-00144ff8d46c

Route

topical

Published

Effective Date 2016-11-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (62 g)

Inactive Ingredients

fd&c yellow no. 5 polyoxyl 40 hydrogenated castor oil carbomer interpolymer type a (55000 cps) water trolamine hydrolyzed jojoba esters (acid form)

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2016-11-01

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Yellow No. 5, Fragrance, Jojoba Esters, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

Description

Alcohol 62%

Questions?

■ 1-888-287-1915

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Package Label

Active Ingredient

Alcohol 62%

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

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Yellow No. 5, Fragrance, Jojoba Esters, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

Questions?

■ 1-888-287-1915

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Package Label

Active Ingredient

Alcohol 62%

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": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROLYZED JOJOBA ESTERS (ACID FORM)", "unii": "UDR641JW8W", "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?": "■ 1-888-287-1915", "Active Ingredient": "Alcohol 62%", "Other information": "■ Store below 105°F ■ May discolor some fabrics", "Inactive Ingredients": "Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Yellow No. 5, Fragrance, Jojoba Esters, PEG-40 Hydrogenated Castor Oil, 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:12.713987 · Updated: 2026-03-14T22:54:32.145936