SPL v2
SPL
SPL Set ID a3404ae7-ff85-73d7-e053-2a95a90a3c26
Route
TOPICAL
Published
Effective Date 2020-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Glycerin Trolamine Carbomer Homopolymer, Unspecified Type Polysorbate 80 Green Tea Leaf Dipropylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-14
Description

Alcohol

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Indications and Usage

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage and Administration

Pump 1-2 times and rub it into your hand. For topical use only.

Description

Alcohol

Section 44425-7

■ Store between 15-30℃ (59-86℉).

■ Avoid freezing and excessive heat above 40℃ (104℉).

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

■ in children less than 2 months of age

■ on open skin wounds

Section 51727-6

Carbomer, Dipropylene glycol, Fragrance, Glycerin, Green tea extract, Polysorbate 80, Purified water, Triethanolamine

Section 51945-4

Section 55105-1

Antiseptic

Instant hand sanitizer to decrease bacteria on the skin

Section 55106-9

Alcohol

Structured Label Content

Indications and Usage (34067-9)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage and Administration (34068-7)

Pump 1-2 times and rub it into your hand. For topical use only.

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Section 44425-7 (44425-7)

■ Store between 15-30℃ (59-86℉).

■ Avoid freezing and excessive heat above 40℃ (104℉).

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

■ in children less than 2 months of age

■ on open skin wounds

Section 51727-6 (51727-6)

Carbomer, Dipropylene glycol, Fragrance, Glycerin, Green tea extract, Polysorbate 80, Purified water, Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Instant hand sanitizer to decrease bacteria on the skin

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:04.381382 · Updated: 2026-03-14T22:57:25.927839