SPL v2
SPL
SPL Set ID 45352bed-42d5-463c-9edd-853a1932fe92
Route
TOPICAL
Published
Effective Date 2013-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-06-18
Description

Active Ingredient Ethyl Alcohol 62%

Medication Information

Warnings and Precautions
Warnings: For external use only. Flammable. Keep away from fire or flame. 
Do not apply around eyes. Do not use in ears or mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
Indications and Usage

Kills 99.99% of Germs With Moisturizers & Vitamin E

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.

Dosage and Administration
Directions: Pump as needed into palms and thoroughly spread on both hands.                                                                                                                                                                         
Rub into skin until dry. 
Other information: Do not store in temperature above 118 F.  
Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1
Keep out of reach of children. 
Use only under adult supervision.
Section 50566-9
Stop use and consult a doctor if redness or irritation develops and persists for more than 72 hours.


Section 51727-6
INACTIVE INGREDIENTS:
Water, Glycerin, Propylene Glycol, Carbomer
Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active Ingredient
Ethyl Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)

Kills 99.99% of Germs With Moisturizers & Vitamin E

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.

Dosage and Administration (34068-7)
Directions: Pump as needed into palms and thoroughly spread on both hands.                                                                                                                                                                         
Rub into skin until dry. 
Other information: Do not store in temperature above 118 F.  
Warnings and Precautions (34071-1)
Warnings: For external use only. Flammable. Keep away from fire or flame. 
Do not apply around eyes. Do not use in ears or mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
Section 50565-1 (50565-1)
Keep out of reach of children. 
Use only under adult supervision.
Section 50566-9 (50566-9)
Stop use and consult a doctor if redness or irritation develops and persists for more than 72 hours.


Section 51727-6 (51727-6)
INACTIVE INGREDIENTS:
Water, Glycerin, Propylene Glycol, Carbomer
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.719359 · Updated: 2026-03-14T22:53:30.775793