SPL v1
SPL
SPL Set ID 3f8b6baa-4896-376c-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
Glycerin Carbomer 940 Aminomethylpropanol Propylene Glycol .alpha.-tocopherol Acetate Fd&c Red No. 40 Grapefruit Seed Oil Water Isopropyl Alcohol Isopropyl Myristate Aloe Vera Leaf Sunflower Seed

Identifiers & Packaging

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

Description

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
  • recommened for repeated use
Dosage and Administration

Directions

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

Ethyl Alcohol 62%

Section 50565-1

Keep out of children

If accidently swallowed, get medical help or contact a Poison Control Center right away

Section 50568-5

Discontinue use if irritation or redness develop. If irritation persists for more than 72 hrs, consult a doctor

Section 51727-6

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Proylene glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Actetate, Sunflower (Helianthus Annuus) Seed Extract, Grapefruit (Citrus Grandis), Seed Extract, Red 40 (Cl 16035), Red 33 (Cl 17200)

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

Ethyl Alcohol 62%

Section 60561-8

Other Information

  • May discolor certain fabrics or surfaces
  • do not store above 110 F ( 43 C)

Structured Label Content

Indications and Usage (34067-9)

Use

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

Directions

  • apply to hands until thoroughly wet
  • rub vigorously unti 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 help or contact a Poison Control Center right away

Section 50568-5 (50568-5)

Discontinue use if irritation or redness develop. If irritation persists for more than 72 hrs, consult a doctor

Section 51727-6 (51727-6)

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Proylene glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Actetate, Sunflower (Helianthus Annuus) Seed Extract, Grapefruit (Citrus Grandis), Seed Extract, Red 40 (Cl 16035), Red 33 (Cl 17200)

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)

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other Information

  • May discolor certain fabrics or surfaces
  • do not store above 110 F ( 43 C)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)