SPL v1
SPL
SPL Set ID ab784403-0f62-37e6-e053-2a95a90a9026
Route
TOPICAL
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Propanediol Trolamine Carbomer Interpolymer Type A (55000 Cps) Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-28

Description

Alcohol 75%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Alcohol 75%

Use

Use to clean hands to reduce bacteria.

Label

Storage

Store between 15-30C (15-30F). In a cool dry place. Prevent direct sunlight.

Stop Use

Stop use and ask a doctor if irritation or allergy occurs.

Warnings

For external use only. Discontinue use if irritation or allergy occurs. Flammable, keep away from heat and flame.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

In children less than 2 months of age.

Avoid contact with eyes, mouth and wounds. In case of contact with eyes, rinse eyes thoroughly with water.

Active Ingredient

Alcohol 75%

Inactive Ingredients

Water,

Carbomer,

Glycerin,

Propanediol,

Triethanolamine

Keep Out of Reach of Children

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


Structured Label Content

Use

Use to clean hands to reduce bacteria.

Label

Purpose

Antimicrobial

Storage

Store between 15-30C (15-30F). In a cool dry place. Prevent direct sunlight.

Stop Use (Stop use)

Stop use and ask a doctor if irritation or allergy occurs.

Warnings

For external use only. Discontinue use if irritation or allergy occurs. Flammable, keep away from heat and flame.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

In children less than 2 months of age.

Avoid contact with eyes, mouth and wounds. In case of contact with eyes, rinse eyes thoroughly with water.

Active Ingredient

Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water,

Carbomer,

Glycerin,

Propanediol,

Triethanolamine

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

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