Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 4d42ff93-c0ee-4c05-af2d-c3b5d5733e66
Route
TOPICAL
Published
Effective Date 2012-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Trolamine Carbomer Homopolymer Type A Aloe Vera Leaf Glycerin Alpha-tocopherol Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-03

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions


Warnings:



For external use only



Flammable



Keep away from fire or flame



Keep out of eyes

Indications and Usage


Uses:



    * Hand Sanitizer to help decrease bacteria on the skin.

  

    * Recommended for repeated use.

Dosage and Administration


Directions:



Apply to hands freely without water. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Description

Active Ingredient Ethyl Alcohol 62%

Section 44425-7


Other Information



Store at 20C (68-77F)



Do not store above 40C (105F)



May discolor fabrics

Section 50565-1


Keep out of Reach of Children

Children must be supervised in use of this product



Section 50569-3


Stop use and seek a doctor if redness or irritation develop and persist for more than 72 hours.

Section 51727-6


Inactive Ingredients:



Water, Triethanolamine, Carbomer, Aloe Barbadensis Gel, Glycerin, Propylene Glycol, Tocopherol, FD and C Red No. 40.

Section 51945-4

label

Section 55105-1

Purpose:

Antiseptic



Section 55106-9

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)


Uses:



    * Hand Sanitizer to help decrease bacteria on the skin.

  

    * Recommended for repeated use.

Dosage and Administration (34068-7)


Directions:



Apply to hands freely without water. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Warnings and Precautions (34071-1)


Warnings:



For external use only



Flammable



Keep away from fire or flame



Keep out of eyes

Section 44425-7 (44425-7)


Other Information



Store at 20C (68-77F)



Do not store above 40C (105F)



May discolor fabrics

Section 50565-1 (50565-1)


Keep out of Reach of Children

Children must be supervised in use of this product



Section 50569-3 (50569-3)


Stop use and seek a doctor if redness or irritation develop and persist for more than 72 hours.

Section 51727-6 (51727-6)


Inactive Ingredients:



Water, Triethanolamine, Carbomer, Aloe Barbadensis Gel, Glycerin, Propylene Glycol, Tocopherol, FD and C Red No. 40.

Section 51945-4 (51945-4)

label

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)