SPL v1
SPL
SPL Set ID 164fd211-0011-7b28-e063-6294a90ac0fe
Route
TOPICAL
Published
Effective Date 2024-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Maltodextrin Aminomethyl Propanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-17

Description

Alcohol Denat 65%


Medication Information

Warnings and Precautions

Flammable, keep away from fire or flame. For external use only. Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention. Stop use and ask doctor if irritation adn redness develop and persists for more than 72 hours.

Indications and Usage

For handwashing to decrease becteria on the skin. Recommended for repeated use.

Dosage and Administration

Dispense an adequate amount in your palm to cover all surfaces of hands completely. Rub hands together until dry. Does not require rinsing.

Description

Alcohol Denat 65%

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

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, aminomethyl propanol.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Alcohol Denat 65%


Structured Label Content

Indications and Usage (34067-9)

For handwashing to decrease becteria on the skin. Recommended for repeated use.

Dosage and Administration (34068-7)

Dispense an adequate amount in your palm to cover all surfaces of hands completely. Rub hands together until dry. Does not require rinsing.

Warnings and Precautions (34071-1)

Flammable, keep away from fire or flame. For external use only. Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention. Stop use and ask doctor if irritation adn redness develop and persists for more than 72 hours.

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)

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, aminomethyl propanol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Alcohol Denat 65%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)