912eeb77-503c-48ec-e053-2995a90ada62

SPL v1

SPL

SPL Set ID 912eeb77-503c-48ec-e053-2995a90ada62

Route

topical

Published

Effective Date 2019-08-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (62 mL)

Inactive Ingredients

.alpha.-tocopherol maltodextrin aloe vera leaf water glycerin propylene glycol carbomer copolymer type a (allyl pentaerythritol crosslinked) trolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2019-08-28

Description

Active Ingredients: Ethanol 62%

Medication Information

Warnings and Precautions

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use in the eyes.

Active Ingredient

Active Ingredients:

Ethanol 62%

Indications and Usage

Use

To decrease bacteria on the skin .

Dosage and Administration

Directions

Rub into skin until dry.

Description

Active Ingredients: Ethanol 62%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.

Section 51727-6

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 60561-8

Other Information

Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use in the eyes.

Active Ingredient (55106-9)

Active Ingredients:

Ethanol 62%

Indications and Usage (34067-9)

Use

To decrease bacteria on the skin .

Dosage and Administration (34068-7)

Directions

Rub into skin until dry.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 60561-8 (60561-8)

Other Information

Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture.

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use To decrease bacteria on the skin .", "34068-7": "Directions Rub into skin until dry.", "34071-1": "Warnings Flammable. Keep away from fire or flame. For external use only. Do not use in the eyes.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.", "51727-6": "Inactive ingredients Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredients: Ethanol 62%", "60561-8": "Other Information Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:51.059688 · Updated: 2026-03-14T22:55:36.629297