SPL v3
SPL
SPL Set ID f79dbac0-cec0-46bc-e053-6294a90a2b13
Route
TOPICAL
Published
Effective Date 2023-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-24

Description

Alcohol 75% v/v. Purpose: Antiseptic


Medication Information

Warnings and Precautions

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

Indications and Usage

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

Place enough product on hands to cover all surfaces.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Section 44425-7

Store between 15-30C (59-86F).



Avoid freezing and excessive heat above 40C (104F) .

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

in children less than 2 months of age.



on open skin wounds.

Section 51727-6

Cellulose and water.

Section 51945-4

Section 55105-1

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 55106-9

Alcohol 75% v/v. Purpose: Antiseptic


Structured Label Content

Indications and Usage (34067-9)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Place enough product on hands to cover all surfaces.

Warnings and Precautions (34071-1)

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

Section 44425-7 (44425-7)

Store between 15-30C (59-86F).



Avoid freezing and excessive heat above 40C (104F) .

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

in children less than 2 months of age.



on open skin wounds.

Section 51727-6 (51727-6)

Cellulose and water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 55106-9 (55106-9)

Alcohol 75% v/v. Purpose: Antiseptic


Advanced Ingredient Data


Raw Label Data

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