SPL v1
SPL
SPL Set ID 3f8ed4b8-0b00-2ebb-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (620 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Propylene Glycol Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Fd&c Blue No. 1 Carbomer 940 Aminomethylpropanol Sunflower Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-02

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

Recommened 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 reach of children

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

Section 50569-3

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

Section 50741-8

Do not get into eyes

If contact occurs, rinse thoroughly with water

Section 51727-6

Inactive Ingredients - Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annulus) seed extract, Blue 1 (Cl 42090)

Section 51945-4

Section 55105-1

Purpose - Antiseptic

Section 55106-9

Active Ingredient - Ethyl Alcohol 62%

Section 60561-8

Other Information

  • May discolour 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 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 reach of children

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

Section 50569-3 (50569-3)

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

Section 50741-8 (50741-8)

Do not get into eyes

If contact occurs, rinse thoroughly with water

Section 51727-6 (51727-6)

Inactive Ingredients - Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annulus) seed extract, Blue 1 (Cl 42090)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antiseptic

Section 55106-9 (55106-9)

Active Ingredient - Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other Information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)