SPL v2
SPL
SPL Set ID af0a9f81-04e6-4906-bf34-c54fad3914b0
Route
TOPICAL
Published
Effective Date 2020-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Water Glycerin .alpha.-tocopherol Sage Oil Hydrogen Peroxide Sodium Pyruvate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01
Description

Ethyl alcohol 80%

Purpose

Antiseptic skin cleanser

Medication Information

Purpose

Antiseptic skin cleanser

Description

Ethyl alcohol 80%

Uses

 For personal hand hygiene to help prevent the spread of bacteria

Label

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a healthcare professional if irritation develops.

Flammable. Keep away from open flame and sources of heat

Directions
  • Adults and children over 2 years: ∙ 
  • For occasional and personal domestic use ∙ 
  • Supervise children when they use this product ∙
  •  Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Active Ingredient

Ethyl alcohol 80%

Other Information

Store at 68° to 70° F (20° to 25° C). May discolor certain fabrics or surfaces.

Inactive Ingredients

Aqua, Glycerin, Vitamin E, Sage Oil, Hydrogen peroxide, Sodium pyruvate

Keep Out of Reach of Children.

 If swallowed, contact a Poison Control Center or , get medical help right away.

Structured Label Content

Uses

 For personal hand hygiene to help prevent the spread of bacteria

Label

Purpose

Antiseptic skin cleanser

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a healthcare professional if irritation develops.

Flammable. Keep away from open flame and sources of heat

Directions
  • Adults and children over 2 years: ∙ 
  • For occasional and personal domestic use ∙ 
  • Supervise children when they use this product ∙
  •  Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Active Ingredient

Ethyl alcohol 80%

Other Information

Store at 68° to 70° F (20° to 25° C). May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Vitamin E, Sage Oil, Hydrogen peroxide, Sodium pyruvate

Keep Out of Reach of Children. (Keep out of reach of children.)

 If swallowed, contact a Poison Control Center or , get medical help right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:48.253303 · Updated: 2026-03-14T22:59:54.471917