SPL v1
SPL
SPL Set ID c28c59a2-cfdb-4ca5-9a00-9cd76df2a1e6
Route
TOPICAL
Published
Effective Date 2014-09-03
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-03
Description

Active ingredients 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

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

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


Description

Active ingredients Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 51727-6

INACTIVE INGREDIENTS:Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice

Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active ingredients
Ethyl Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
Directions: Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.                                                                                                                                                                          
Other information: Do not store in temperature over 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. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use or ask for 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, Triethanolamine, Aloe Barbadensis Leaf Juice

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:49.896668 · Updated: 2026-03-14T22:53:47.887144