Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID c209a4c0-fe95-4427-a47a-7d007f3bce41
Route
TOPICAL
Published
Effective Date 2010-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62.00 g)
Inactive Ingredients
Water Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Carbomer Copolymer Type A Trolamine Anhydrous Lactose Cellulose, Microcrystalline Edetate Disodium D&c Red No. 33 Fd&c Yellow No. 5 Hypromellose 2208 (15000 Cps) Alpha-tocopherol Acetate Ascorbyl Palmitate Grapefruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-10

Description

Active ingredients                                                Ethyl Alcohol 62%                                          


Medication Information

Warnings and Precautions

Warnings



For external use only



Flammable: Keep away from heat and flame



Other Information:



Do not store above 105F



May discolor some fabrics



Harmful to wood finishes and plastics



Indications and Usage

Uses 



To decrease bacteria on hands that can cause disease



Recommended for repeated use.

Dosage and Administration
Directions  



Wet hands thoroughly with products and allow to dry without wiping.
Description

Active ingredients                                                Ethyl Alcohol 62%                                          

Section 50565-1

For children under 6, use under adult supervision

Not recommended for infants.

Section 51727-6
Inactive Ingredients



Water, Propylene Glycol,  PEG-40 Hydrogenated Castor Oil, Fragrance, Carbomer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Ester, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, D and C red No. 33, FD and C Yellow No. 5
Section 51945-4


label
Section 55105-1

Purpose:



Antiseptic

.

Section 55106-9

Active ingredients                                               

Ethyl Alcohol 62%

                                         


Structured Label Content

Indications and Usage (34067-9)

Uses 



To decrease bacteria on hands that can cause disease



Recommended for repeated use.

Dosage and Administration (34068-7)
Directions  



Wet hands thoroughly with products and allow to dry without wiping.
Warnings and Precautions (34071-1)

Warnings



For external use only



Flammable: Keep away from heat and flame



Other Information:



Do not store above 105F



May discolor some fabrics



Harmful to wood finishes and plastics



Section 50565-1 (50565-1)

For children under 6, use under adult supervision

Not recommended for infants.

Section 51727-6 (51727-6)
Inactive Ingredients



Water, Propylene Glycol,  PEG-40 Hydrogenated Castor Oil, Fragrance, Carbomer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Ester, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, D and C red No. 33, FD and C Yellow No. 5
Section 51945-4 (51945-4)


label
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)