SPL v3
SPL
SPL Set ID bc7f53b6-2757-45d4-a806-8e9d513b04c3
Route
TOPICAL
Published
Effective Date 2012-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-30

Description

Active ingredients Ethyl Alcohol 62% v/v


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 ingredients Ethyl Alcohol 62% v/v

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.33

Section 51945-4
Section 55105-1
Purpose

Antimicrobial
Section 55106-9
Active ingredients

Ethyl Alcohol 62% v/v


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.33

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

Antimicrobial
Section 55106-9 (55106-9)
Active ingredients

Ethyl Alcohol 62% v/v


Advanced Ingredient Data


Raw Label Data

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