SPL v1
SPL
SPL Set ID 86a4f6dc-4f2c-47f5-aaed-c4bfad9060b4
Route
TOPICAL
Published
Effective Date 2014-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-15

Description

Active ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings:

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

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

Indications and Usage

Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and Administration
Directions:

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

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

Other Information: Do not store above 110 F.  May discolor some fabrics.


Description

Active ingredients Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6

Inactive Ingredients:Water, Aloe barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, 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: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and Administration (34068-7)
Directions:

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

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

Other Information: Do not store above 110 F.  May discolor some fabrics.


Warnings and Precautions (34071-1)

Warnings:

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6 (51727-6)

Inactive Ingredients:Water, Aloe barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, 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)