SPL v2
SPL
SPL Set ID 6d7b95f9-214b-40fd-93c6-d4e1c420bdba
Route
TOPICAL
Published
Effective Date 2020-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 ng)
Inactive Ingredients
Water Glycerin Apricot Kernel Oil Bergamot 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.

Package

Warnings

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

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.

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

Ethyl alcohol 80%

Inactive Ingredients

Water (Aqua), Glycerin, Apricot kernel oil, Bergamot leaf oil, Hydrogen peroxide, Sodium pyruvate

Other information

Store at 68° to 70° F (20° to 25° C).

May discolor certain fabrics or surfaces.

Questions? 1-844-800-6858

Keep Out of Reach of Children.

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

Structured Label Content

Uses

For personal hand hygiene to help prevent the spread of bacteria.

Package

Purpose

Antiseptic skin cleanser

Warnings

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

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.

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

Ethyl alcohol 80%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Apricot kernel oil, Bergamot leaf oil, Hydrogen peroxide, Sodium pyruvate

Other information

Store at 68° to 70° F (20° to 25° C).

May discolor certain fabrics or surfaces.

Questions? 1-844-800-6858

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:47.114444 · Updated: 2026-03-14T22:59:54.471917