SPL v1
SPL
SPL Set ID a56b7369-c972-4dcc-e053-2a95a90a638b
Route
TOPICAL
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (210 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Carbomer 940 Aminomethylpropanol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-12

Description

Alcohol


Medication Information

Warnings and Precautions

■ Flammable. Keep away from fire or flame.

■ For external use only.

Indications and Usage

■ Hand sanitizer to help reduce bacteria on the skin.

Dosage and Administration

Pump 1-2 times and rub it into your hand. For topical use only.

Description

Alcohol

Section 44425-7

Store below 110℉(43℃)

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 appears and lasts

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 50570-1

■ in children less than 2 months of age

■ on open skin wounds

Section 51727-6

Water(Aqua), Glycerin, Carbomer, Aloe Barbadensis Leaf Juice(Aloe Vera), Tocopheryl Acetate(Vitamin E), Phenoxyethanol, Aminomethyl propanol

Section 51945-4

Section 55105-1

Antimicrobial

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

■ Hand sanitizer to help reduce bacteria on the skin.

Dosage and Administration (34068-7)

Pump 1-2 times and rub it into your hand. For topical use only.

Warnings and Precautions (34071-1)

■ Flammable. Keep away from fire or flame.

■ For external use only.

Section 44425-7 (44425-7)

Store below 110℉(43℃)

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 appears and lasts

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, 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)

Water(Aqua), Glycerin, Carbomer, Aloe Barbadensis Leaf Juice(Aloe Vera), Tocopheryl Acetate(Vitamin E), Phenoxyethanol, Aminomethyl propanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)