SPL v1
SPL
SPL Set ID bcf1dcb6-1f11-45bf-9d7c-485e8da01cd7
Route
TOPICAL
Published
Effective Date 2014-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Aloe Vera Leaf D&c Red No. 33 .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-26

Description

Active Ingredients 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 hands until dry. 
Other Information:
Store below 110 F.


Description

Active Ingredients 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 OR PHYSICIAN.

Section 51727-6

Inactive Ingredients:

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Blue No.1, D&C Red No.33

Section 51945-4
Section 55105-1

Purpose

Antimicrobial

Section 55106-9
Active Ingredients
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 hands 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 OR PHYSICIAN.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Tocopheryl Acetate, FD&C Blue No.1, D&C Red No.33

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

Purpose

Antimicrobial

Section 55106-9 (55106-9)
Active Ingredients
Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)