SPL v1
SPL
SPL Set ID 5b6776a9-9175-4b1d-9713-dfa0411bad77
Route
TOPICAL
Published
Effective Date 2013-08-20
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 Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-20
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 Yellow NO.5, FD&C Blue NO.1

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 Yellow NO.5, FD&C Blue NO.1

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:41.050501 · Updated: 2026-03-14T22:53:34.467425