SPL v1
SPL
SPL Set ID 3f8bfbc5-c5bf-1523-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (620 mL)
Inactive Ingredients
Fd&c Red No. 40 Isopropyl Alcohol Glycerin Carbomer 940 Aminomethylpropanol Propylene Glycol Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Sunflower Seed Grapefruit Seed Oil Fd&c Yellow No. 6 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-01-10
Description

Active Ingredient - Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings

for external use only

Flammable, keep away from fire or flame

Indications and Usage

Use

  • to decrease bacteria on the skin and clean hands
  • recommeded for repeated use
Dosage and Administration

Directions

  • apply to hands until thoroughly wet
  • rub vigorously until dry
  • supervise children in the use of this product
Description

Active Ingredient - Ethyl Alcohol 62%

Section 50565-1

Keep out of children. If accidently swallowed, get medical helpor contact a Poison Control Center right away

Section 50568-5

Discontinue Use if irritation or redness develops, If irritation persists for more than 72 hours, consult a doctor

Section 51727-6

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Prpanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Heilanthus Annuus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, yellow 6 (Cl 15985) Red 40 (Cl 16035)

Section 51945-4

Section 54433-8

Do not get into eyes, If contact occurs, rinse thoroughly with water

Section 55105-1

Purpose - Antiseptic

Section 55106-9

Active Ingredient - Ethyl Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)

Use

  • to decrease bacteria on the skin and clean hands
  • recommeded for repeated use
Dosage and Administration (34068-7)

Directions

  • apply to hands until thoroughly wet
  • rub vigorously until dry
  • supervise children in the use of this product
Warnings and Precautions (34071-1)

Warnings

for external use only

Flammable, keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of children. If accidently swallowed, get medical helpor contact a Poison Control Center right away

Section 50568-5 (50568-5)

Discontinue Use if irritation or redness develops, If irritation persists for more than 72 hours, consult a doctor

Section 51727-6 (51727-6)

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Prpanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Heilanthus Annuus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, yellow 6 (Cl 15985) Red 40 (Cl 16035)

Section 51945-4 (51945-4)

Section 54433-8 (54433-8)

Do not get into eyes, If contact occurs, rinse thoroughly with water

Section 55105-1 (55105-1)

Purpose - Antiseptic

Section 55106-9 (55106-9)

Active Ingredient - Ethyl Alcohol 62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:12.132454 · Updated: 2026-03-14T22:54:30.332332