SPL v3
SPL
SPL Set ID 1b5e7620-66df-43f6-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Fd&c Blue No. 1 Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Trolamine Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-21

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 hands until dry.

Description

Active Ingredient: Ethyl Alcohol 62%

Section 44425-7

Other Information:

Store below 110 F.

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

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Fragrance, Carbomer, Triethanolamine, FD&C Blue No.1, FD&C Yellow No.5.

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 hands until dry.

Warnings and Precautions (34071-1)

WARNING:

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.

Section 44425-7 (44425-7)

Other Information:

Store below 110 F.

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)

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Fragrance, Carbomer, Triethanolamine, FD&C Blue No.1, FD&C Yellow No.5.

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)