SPL v1
SPL
SPL Set ID cbcc9dc2-2aa3-4a31-a6de-18472fc54676
Route
TOPICAL
Published
Effective Date 2013-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Trolamine .alpha.-tocopherol Acetate Fd&c Red No. 4 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-16

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions
WARNING:
Flammable;
Keep away from fire or flame;
FOR EXTERNAL USE ONLY;
DO NOT USE IN THE EYES.


Indications and Usage
KILLS MORE THAN 99.99% OF COMMON GERMS

Dosage and Administration
DIRECTIONS:
Rub into skin until dry.
 
Other Information:
Store below 110 F.


Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1
Keep out of reach of children.

Section 50566-9
DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.


Section 51727-6

INACTIVE INGREDIENTS:

Water, Aloe barbadenis, Leaf Juice, Glycerin,

Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Red No. 4, FD&C Red No. 33

Section 51945-4
Section 55105-1
Purpose

Antimicrobial
Section 55106-9
Active Ingredient
Ethyl Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)
KILLS MORE THAN 99.99% OF COMMON GERMS

Dosage and Administration (34068-7)
DIRECTIONS:
Rub into skin until dry.
 
Other Information:
Store below 110 F.


Warnings and Precautions (34071-1)
WARNING:
Flammable;
Keep away from fire or flame;
FOR EXTERNAL USE ONLY;
DO NOT USE IN THE EYES.


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

Section 50566-9 (50566-9)
DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.
IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.


Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Water, Aloe barbadenis, Leaf Juice, Glycerin,

Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Red No. 4, FD&C Red No. 33

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

Antimicrobial
Section 55106-9 (55106-9)
Active Ingredient
Ethyl Alcohol 62%

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)