Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d96fc88d-cfed-4b25-a565-3a559a432882
Route
TOPICAL
Published
Effective Date 2020-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Aloe Vera Leaf Althaea Officinalis Root Camellia Sinensis Flower Avena Sativa Leaf Camellia Reticulata Seed Oil Cucumis Sativus Leaf Glycerin Water Lavandula Angustifolia Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-10

Description

Ethyl Alcohol 65%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Use

• For hand sanitizing to decrease bacteria on the skin when water and soap are not available. • Recommened for repeated use.

Section 50565-1

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop Use and ask doctor if irritation or redness persisits for more than 72 hours.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Remove wipe. • Wet hands thoroughly with wipe and allow hands to dry without wiping.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 65%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Althaea Officinalis Root Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Lavendula Angustifolia (Lavender) Oil, Water.

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Structured Label Content

Use

• For hand sanitizing to decrease bacteria on the skin when water and soap are not available. • Recommened for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop Use and ask doctor if irritation or redness persisits for more than 72 hours.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Remove wipe. • Wet hands thoroughly with wipe and allow hands to dry without wiping.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 65%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Althaea Officinalis Root Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Lavendula Angustifolia (Lavender) Oil, Water.

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Advanced Ingredient Data


Raw Label Data

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