Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 29765b23-6de4-444b-8c9a-7894fccfa0f3
Route
TOPICAL
Published
Effective Date 2010-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Propylene Glycol Glycerin Aloe Vera Leaf Carbomer Homopolymer Type C Alpha-tocopherol Trolamine Pomegranate D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-13

Description

Active Ingredient Ethyl Alcohol 62%  


Medication Information

Warnings and Precautions


Warnings:



For external use only-hands.

Use only as directed.

Excessive use or prolonged exposure may cause irritation to the skin.

Discontinue use if irritation, redness, or itching occurs.

Flammable. Keep away from heat and flame

Indications and Usage


Uses:



To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and Administration

Directions:

Put a thumb size amount in your palm and rub hands together briskly until dry

Description

Active Ingredient Ethyl Alcohol 62%  

Section 44425-7

Other Information

Do not store in temperatures over 118F

Children under six years of age should be supervised while using this product.

May discolor certain fabrics

Section 50565-1




Keep Out of Reach of Children:



In case of accidental ingestion, seek professional assistance of contact a Poison Control center immediately

Section 50567-7

When Using This Product:

Keep out of eyes. In case of contact with eyes, flush immediately with water and call a doctor.

Avoid contact with broken skin



Section 50569-3


Stop Use And Ask A Doctor if irritation or redness develops



Section 51727-6




Inactive Ingredients



aloe barbadensis gel, carbomer, deionized water, Fragrance, glycerin, propylene glycol, D and C Red No. 33, triethanolamine, and vitamin E

Section 51945-4

labe

Section 55105-1


Purpose:



Sanitizer

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%  


Structured Label Content

Indications and Usage (34067-9)


Uses:



To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Put a thumb size amount in your palm and rub hands together briskly until dry

Warnings and Precautions (34071-1)


Warnings:



For external use only-hands.

Use only as directed.

Excessive use or prolonged exposure may cause irritation to the skin.

Discontinue use if irritation, redness, or itching occurs.

Flammable. Keep away from heat and flame

Section 44425-7 (44425-7)

Other Information

Do not store in temperatures over 118F

Children under six years of age should be supervised while using this product.

May discolor certain fabrics

Section 50565-1 (50565-1)




Keep Out of Reach of Children:



In case of accidental ingestion, seek professional assistance of contact a Poison Control center immediately

Section 50567-7 (50567-7)

When Using This Product:

Keep out of eyes. In case of contact with eyes, flush immediately with water and call a doctor.

Avoid contact with broken skin



Section 50569-3 (50569-3)


Stop Use And Ask A Doctor if irritation or redness develops



Section 51727-6 (51727-6)




Inactive Ingredients



aloe barbadensis gel, carbomer, deionized water, Fragrance, glycerin, propylene glycol, D and C Red No. 33, triethanolamine, and vitamin E

Section 51945-4 (51945-4)

labe

Section 55105-1 (55105-1)


Purpose:



Sanitizer

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%  


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)