SPL v1
SPL
SPL Set ID 664dc461-4be0-49e0-bf2b-4a3ce0606cd8
Route
TOPICAL
Published
Effective Date 2018-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Isopropyl Alcohol Lavender Oil Glycerin Aloe Vera Leaf Cucumber Chamomile Oat Althaea Officinalis Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-01

Description

Ethyl Alcohol 65% V/V

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 65% V/V

Uses
  • for hand sanitizing to decrease bacteria on skin when water and soap are not available.
  • recommended for repeated use.
Section 51945-4

Warnings

For external use only. Flammable: keep away from fire or flame. When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water. Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

Directions
  • remove wipe
  • wet hands thoroughly with wipe and allow hands to dry without wiping
Active Ingredient

Ethyl Alcohol 65% V/V

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerin, Lavandula Angustifolia (Lavender) Oil, Organic Aloe Barbadensis Leaf Extract, Organic Althaea Officinalis Root Extract, Organic Avena Sativa (Oats) Extract, Organic Camellia Sinensis (White Tea) Leaf Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Cucumis Sativus (Cucumber) Fruit Extract

Questions, Comments?
Keep Out of Reach of Children

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


Structured Label Content

Uses
  • for hand sanitizing to decrease bacteria on skin when water and soap are not available.
  • recommended for repeated use.
Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only. Flammable: keep away from fire or flame. When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water. Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

Directions
  • remove wipe
  • wet hands thoroughly with wipe and allow hands to dry without wiping
Active Ingredient

Ethyl Alcohol 65% V/V

Inactive Ingredients (Inactive ingredients)

Water, Isopropyl Alcohol, Glycerin, Lavandula Angustifolia (Lavender) Oil, Organic Aloe Barbadensis Leaf Extract, Organic Althaea Officinalis Root Extract, Organic Avena Sativa (Oats) Extract, Organic Camellia Sinensis (White Tea) Leaf Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Cucumis Sativus (Cucumber) Fruit Extract

Questions, Comments?
Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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