SPL v1
SPL
SPL Set ID ab3ac83b-d549-72a8-e053-2a95a90a004f
Route
TOPICAL
Published
Effective Date 2020-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-11

Description

Ethyl Alcohol 75%

Purpose

Anitbacterial


Medication Information

Purpose

Anitbacterial

Description

Ethyl Alcohol 75%

Use

decrease bacteria on skin

Warnings

For external use only.

Directions

adult and children 2years and over

  • apply to hands
  • allow to dry without wiping

children under 2 years

  • ask a doctor before use
Do Not Use

If you are allergic to any of the ingredients

Active Ingredient

Ethyl Alcohol 75%

Inactive Ingredients

Water

Glycerin

Aloe barbadensis extract

When Using This Product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



Stop Use and Ask A Doctor

Stop use and ask a doctor if irritation or rash occurs develops and continues for more than 72 hours

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.

Package Label Principal Display Panel


Structured Label Content

Use

decrease bacteria on skin

Purpose

Anitbacterial

Warnings

For external use only.

Directions

adult and children 2years and over

  • apply to hands
  • allow to dry without wiping

children under 2 years

  • ask a doctor before use
Do Not Use (Do not use)

If you are allergic to any of the ingredients

Active Ingredient

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water

Glycerin

Aloe barbadensis extract

When Using This Product (When using this product)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if irritation or rash occurs develops and continues for more than 72 hours

Keep Out of Reach of Children (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.

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


Advanced Ingredient Data


Raw Label Data

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