SPL v1
SPL
SPL Set ID a78d9b44-31c6-5071-e053-2995a90a206b
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) .alpha.-tocopherol Acetate Aminomethylpropanol Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-08

Description

Active Ingredient[s] Ethyl Alcohol 75% v/v


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Use[s]

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

Dosage and Administration

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.

Description

Active Ingredient[s] Ethyl Alcohol 75% v/v

Section 44425-7

Other information

• Store between 1 – 30°C (59- 86°F)

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

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

Do not use

• in children less than 2 months of age

• on open skin wounds

Section 51727-6

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Maltodextrin.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient[s]

Ethyl Alcohol 75% v/v


Structured Label Content

Indications and Usage (34067-9)

Use[s]

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)

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.

Warnings and Precautions (34071-1)

Warnings

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

Section 44425-7 (44425-7)

Other information

• Store between 1 – 30°C (59- 86°F)

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

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)

Do not use

• in children less than 2 months of age

• on open skin wounds

Section 51727-6 (51727-6)

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Maltodextrin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient[s]

Ethyl Alcohol 75% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)