Drug Fact

Drug Fact
SPL v2
SPL
SPL Set ID af1c3818-f960-48be-8eae-0e9703d20c0d
Route
TOPICAL
Published
Effective Date 2018-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-05

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

For external use only-hands

Flammable: Keep away from heat and flame

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. 



Indications and Usage

Uses

Antiseptic Use for hand washing to decrease bacteria on the skin

Dosage and Administration

Directions

  • Wet hands thoroughly with product. Briskly, rub hands together until dry. Supervise children in the use of this product.

Description

Active Ingredient Ethyl Alcohol 62%

Section 44425-7

Other Information:

  • May discolor some fabrics
  • Store at 20-25 degree C (68-77 degree F)

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

Section 50569-3

Stop use and ask a doctor if skin irritation develops and persist for more than 72 hours

Section 51727-6

Inactive Ingredient:

Deionized Water, Glycerin, Triethanolamine, Carbomer, Fragrance.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Uses

Antiseptic Use for hand washing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • Wet hands thoroughly with product. Briskly, rub hands together until dry. Supervise children in the use of this product.

Warnings and Precautions (34071-1)

For external use only-hands

Flammable: Keep away from heat and flame

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. 



Section 44425-7 (44425-7)

Other Information:

  • May discolor some fabrics
  • Store at 20-25 degree C (68-77 degree F)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation develops and persist for more than 72 hours

Section 51727-6 (51727-6)

Inactive Ingredient:

Deionized Water, Glycerin, Triethanolamine, Carbomer, Fragrance.

Section 51945-4 (51945-4)

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)