SPL v3
SPL
SPL Set ID 87784a00-c38a-430f-828d-9600c0be2a54
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) .alpha.-tocopherol Acetate Apple Glycerin West Indian Lemongrass Oil Tea Leaf Oil Peppermint Oil Lavender Oil Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-26
Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Use
  • Hand Sanitizer to help reduce bacteria  on the skin.
  • For use when soap and water are not available.
Section 50565-1

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

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product Avoid contact with eyes, ears and mouth. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions
  • Apply. Put enough product on hands to cover all surfaces. Rub hands together until feel dry. This should take around 20 seconds.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information
  • Store between 15-30 0C (59-86 0F)
  • Avoid freezing and excessive heat above 40 0C (104 0F)
Inactive Ingredients

Decolorized Aloe Barbadensis Leaf Juice*, Ammonium Polyacryloyldimethyl Taurate, Tocopheryl Acetate (Vitamin E), Pyrus Malus (Apple)

Fruit Extract*, Glycerin*, Lavandula Angustifolia (Lavender) Oil**, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Eucalyptus Globulus (Eucalyptus) Oil*.

Package Label Principal Display Panel

Structured Label Content

Use
  • Hand Sanitizer to help reduce bacteria  on the skin.
  • For use when soap and water are not available.
Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product Avoid contact with eyes, ears and mouth. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions
  • Apply. Put enough product on hands to cover all surfaces. Rub hands together until feel dry. This should take around 20 seconds.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30 0C (59-86 0F)
  • Avoid freezing and excessive heat above 40 0C (104 0F)
Inactive Ingredients (Inactive ingredients)

Decolorized Aloe Barbadensis Leaf Juice*, Ammonium Polyacryloyldimethyl Taurate, Tocopheryl Acetate (Vitamin E), Pyrus Malus (Apple)

Fruit Extract*, Glycerin*, Lavandula Angustifolia (Lavender) Oil**, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Eucalyptus Globulus (Eucalyptus) Oil*.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:10.364493 · Updated: 2026-03-14T23:00:32.199749