SPL v1
SPL
SPL Set ID 7b3f6074-c44b-474b-9e5a-57411ca37b82
Route
TOPICAL
Published
Effective Date 2012-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-28

Description

Active ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions
Warning

For External Use Only.

Flammable, Keep away from fire or flame.
Indications and Usage
Uses

To help reduce bacteria on the hands that can potentially cause disease.

Dosage and Administration
DIRECTIONS:

Apply a liberal amount to hands and rub hands thoroughly until dry. Do not rinse or wipe off gel.

Description

Active ingredients Ethyl Alcohol 62%

Section 50565-1
Keep out of reach of children.

If swallowed get medical help or contact a Poison Control

Center immediately.

Section 50566-9
Stop use and ask a doctor if

significant irritation or sensitization occurs.
Section 50567-7
When using this product

Avoid contact with eyes, if this occurs rinse thoroughly with water and contact a physician.
Section 50569-3
Ask a doctor before use if you have

Deep wounds, animal bites or serious burns.
Section 51727-6
INACTIVE INGREDIENTS:

Deionized water, Aloe barbadenis, Leaf Juice, Glycerin,

Propylene glycol, Carbomer, Aminomethyl Propanol, Fragrance

Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active ingredients

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)
Uses

To help reduce bacteria on the hands that can potentially cause disease.

Dosage and Administration (34068-7)
DIRECTIONS:

Apply a liberal amount to hands and rub hands thoroughly until dry. Do not rinse or wipe off gel.

Warnings and Precautions (34071-1)
Warning

For External Use Only.

Flammable, Keep away from fire or flame.
Section 50565-1 (50565-1)
Keep out of reach of children.

If swallowed get medical help or contact a Poison Control

Center immediately.

Section 50566-9 (50566-9)
Stop use and ask a doctor if

significant irritation or sensitization occurs.
Section 50567-7 (50567-7)
When using this product

Avoid contact with eyes, if this occurs rinse thoroughly with water and contact a physician.
Section 50569-3 (50569-3)
Ask a doctor before use if you have

Deep wounds, animal bites or serious burns.
Section 51727-6 (51727-6)
INACTIVE INGREDIENTS:

Deionized water, Aloe barbadenis, Leaf Juice, Glycerin,

Propylene glycol, Carbomer, Aminomethyl Propanol, Fragrance

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

Antiseptic
Section 55106-9 (55106-9)
Active ingredients

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)