SPL v2
SPL
SPL Set ID be8678ea-44d0-4e05-8de2-dcb69e451fe9
Route
TOPICAL
Published
Effective Date 2012-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-05-20

Description

Active ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions
Warnings

For external use only.
Indications and Usage
Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Flammable. Keep away from heat and flame.
Dosage and Administration
Directions

Wet hands thoroughly with product and allow to dry without wiping

Children under 6 of age should be supervised when using this product.

Not recommended for infants.

Other Information

Do not store above 105 degrees F.

May discolor some fabrics.
Description

Active ingredient Ethyl Alcohol 62%

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
Discontinue Use

if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
Section 50567-7
When using this product

Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.
Section 51727-6
Inactive Ingredients

Water, glycerin, propylene glycol, aloe, fragrance
Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)
Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Flammable. Keep away from heat and flame.
Dosage and Administration (34068-7)
Directions

Wet hands thoroughly with product and allow to dry without wiping

Children under 6 of age should be supervised when using this product.

Not recommended for infants.

Other Information

Do not store above 105 degrees F.

May discolor some fabrics.
Warnings and Precautions (34071-1)
Warnings

For external use only.
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)
Discontinue Use

if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
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. Avoid contact with broken skin.
Section 51727-6 (51727-6)
Inactive Ingredients

Water, glycerin, propylene glycol, aloe, fragrance
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

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

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)