drug facts

drug facts

SPL v2

SPL

SPL Set ID 37754a2e-1dcc-4893-bcf7-70e6543c4d7f

Route

topical

Published

Effective Date 2011-10-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (62 mL)

Inactive Ingredients

sulisobenzone fd&c blue no. 1 fd&c yellow no. 5 glycerin polyoxyl 40 hydrogenated castor oil propylene glycol tocopherol jojoba oil trolamine water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2011-11-15

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

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

Avoid the eyes and mucous membranes.

In case of contact; rinse area thoroughly with water

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antiseptic

Directions

Rub dime sized amount between hands until dry

Other Information

Store below 105F

May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, Fragrance, FDC Blue 1, FDC Yellow 5, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)

Description

Ethyl Alcohol 62%

Package Label

Active Ingredient

Ethyl Alcohol 62%

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

Avoid the eyes and mucous membranes.

In case of contact; rinse area thoroughly with water

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antiseptic

Directions

Rub dime sized amount between hands until dry

Other Information

Store below 105F

May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, Fragrance, FDC Blue 1, FDC Yellow 5, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)

Package Label

Active Ingredient

Ethyl Alcohol 62%

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": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "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", "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 Avoid the eyes and mucous membranes. In case of contact; rinse area thoroughly with water", "Directions": "Rub dime sized amount between hands until dry", "Active Ingredient": "Ethyl Alcohol 62%", "Other Information": "Store below 105F May discolor some fabrics", "Inactive Ingredients": "Benzophenone-4, Carbomer, Fragrance, FDC Blue 1, FDC Yellow 5, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)", "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: 2026-02-15T11:55:48.857686 · Updated: 2026-03-14T22:53:46.796959