Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ad0d266a-584a-23a3-e053-2a95a90af73e
Route
TOPICAL
Published
Effective Date 2020-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Ext. D&c Violet No. 2 Water Aloe Vera Leaf 1,2-hexanediol D&c Red No. 33 Octocrylene Hyaluronate Sodium Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-15
Description

alcohol

Medication Information

Warnings and Precautions

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

1) Hypersensitivity symptoms such as rash, erythema, itching, and edema

2) Skin irritation symptoms

Indications and Usage

Apply an appropriate amount on your hands and rub well until dry.

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

WATER, fragrance, sodium hyaluronate, aloe vera extract, 1,2-hexanediol, octocrylene, CI 17200, CI 60730

Section 51945-4

Section 55105-1

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

Section 55106-9

alcohol

Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount on your hands and rub well until dry.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

1) Hypersensitivity symptoms such as rash, erythema, itching, and edema

2) Skin irritation symptoms

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

WATER, fragrance, sodium hyaluronate, aloe vera extract, 1,2-hexanediol, octocrylene, CI 17200, CI 60730

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic 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: 2026-02-15T11:58:29.262150 · Updated: 2026-03-14T22:58:03.704124