SPL v2
SPL
SPL Set ID 8ac1385e-ff05-48fe-9a85-a8d0210e77eb
Route
TOPICAL
Published
Effective Date 2012-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-18

Description

Active ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions
Warnings

For external use only.

Avoid contact with broken skin.

Flammable. Keep away from heat and flame.

Keep out of reach of children.



Indications and Usage
Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Dosage and Administration
Directions

Not recommanded for infants

Wet hands thoroughly with product and allow to dry without wiping

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

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.

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

Section 51727-6
Inactive Ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, 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

Dosage and Administration (34068-7)
Directions

Not recommanded for infants

Wet hands thoroughly with product and allow to dry without wiping

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

Other Information

Do not store above 105 degrees F.

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

For external use only.

Avoid contact with broken skin.

Flammable. Keep away from heat and flame.

Keep out of reach of children.



Section 50565-1 (50565-1)
Keep out of reach of children.

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

Section 51727-6 (51727-6)
Inactive Ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, 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)