SPL v2
SPL
SPL Set ID ecfa5e4a-ed70-4f32-87ea-0e60c8dac3d0
Route
TOPICAL
Published
Effective Date 2018-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 g)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Aloe Vera Leaf Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-01

Description

Active ingredient Ethanol 70%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product avoid contact with eyes. In case of eye contact, flush eyes

thoroughly with water.

Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

than 72 hours.

Indications and Usage

Uses    •For hand washing to decrease bacteria on the skin

            •Recommended for repeated use

Dosage and Administration

Directions    •Dispense an adeqaute amount in your palm to cover all surfaces of hands

completely.    •Rub hands together until dry   •Supervise children in the use of this product.

Description

Active ingredient Ethanol 70%

Section 44425-7

Other information   •Do not store above 100° F (38° C)   •May discolor some fabrics

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive ingredients   Water (Aqua), Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf

Juice Panthenol

Section 51945-4

Section 53413-1

Questions or comments?   781-03-7800   •[email protected]

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Ethanol 70%


Structured Label Content

Indications and Usage (34067-9)

Uses    •For hand washing to decrease bacteria on the skin

            •Recommended for repeated use

Dosage and Administration (34068-7)

Directions    •Dispense an adeqaute amount in your palm to cover all surfaces of hands

completely.    •Rub hands together until dry   •Supervise children in the use of this product.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product avoid contact with eyes. In case of eye contact, flush eyes

thoroughly with water.

Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

than 72 hours.

Section 44425-7 (44425-7)

Other information   •Do not store above 100° F (38° C)   •May discolor some fabrics

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 51727-6 (51727-6)

Inactive ingredients   Water (Aqua), Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf

Juice Panthenol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?   781-03-7800   •[email protected]

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Ethanol 70%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)