SPL v2
SPL
SPL Set ID 0fbf48b6-13ae-4617-9bfc-8074614fc523
Route
TOPICAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-01

Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Uses

To decrease bacteria on skin.

Section 50565-1

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

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• On open skin wound.

• On children less than 2 months of age.

When using this product keep out of eyes. In case of contact, rinse eyes with water.

Stop use and ask a doctor if irritation or rash appears.

Directions
  • Wipe hands thoroughly with product and allow to dry.
  • Children under 6 years of age must be supervised when using this product.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information



• Store below 40°C (104°F).

• May discolor certain fabric.

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Isopropyl Myristate, Tocopheryl Acetate

Package Label Principal Display Panel


Structured Label Content

Uses

To decrease bacteria on skin.

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• On open skin wound.

• On children less than 2 months of age.

When using this product keep out of eyes. In case of contact, rinse eyes with water.

Stop use and ask a doctor if irritation or rash appears.

Directions
  • Wipe hands thoroughly with product and allow to dry.
  • Children under 6 years of age must be supervised when using this product.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information (OTHER INFORMATION)



• Store below 40°C (104°F).

• May discolor certain fabric.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Isopropyl Myristate, Tocopheryl Acetate

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)