Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID ce94e174-0905-4345-b824-4ef4a2e0bb28
Route
TOPICAL
Published
Effective Date 2010-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Trolamine Carbomer Homopolymer Type A Polyoxyl 40 Hydrogenated Castor Oil Dmdm Hydantoin Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Red No. 40 Sodium Lauryl Sulfate Alpha-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-10-07

Description

Active Ingredient       Ethyl Alcohol     62%


Medication Information

Warnings and Precautions


Warnings:



For external use only



Flammable. Keep away from heat and flame.



When using this product



    * Keep out of eyes.  In case of contact with eyes, flush thoroughly with water

    * Avoid contact with broken skin

    * Do not inhale or ingest



Indications and Usage




Uses:



To decrease bacteria on skin that could cause disease



Recommended for repeated use

Dosage and Administration




Directions:

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

Not recommended for infants
Description

Active Ingredient       Ethyl Alcohol     62%

Section 44425-7




Other Information



    * Do not store above 105F

    * May discolor some fabrics

    * Harmful to wood finishes and plastics
Section 50565-1




Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9


Stop use and ask a doctor if skin irritation develops

Section 51727-6

Water, Sodium Lauryl Sulfate, Carbomer, Glycerin, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, Aloe and Vitamin E Microbeads. May Contain: FD and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

Section 51945-4

fron

Section 55105-1




Purpose                      Antiseptic

Section 55106-9

Active Ingredient      Ethyl Alcohol     62%


Structured Label Content

Indications and Usage (34067-9)




Uses:



To decrease bacteria on skin that could cause disease



Recommended for repeated use

Dosage and Administration (34068-7)




Directions:

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision.

Not recommended for infants
Warnings and Precautions (34071-1)


Warnings:



For external use only



Flammable. Keep away from heat and flame.



When using this product



    * Keep out of eyes.  In case of contact with eyes, flush thoroughly with water

    * Avoid contact with broken skin

    * Do not inhale or ingest



Section 44425-7 (44425-7)




Other Information



    * Do not store above 105F

    * May discolor some fabrics

    * Harmful to wood finishes and plastics
Section 50565-1 (50565-1)




Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)


Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Water, Sodium Lauryl Sulfate, Carbomer, Glycerin, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, Aloe and Vitamin E Microbeads. May Contain: FD and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

Section 51945-4 (51945-4)

fron

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)