SPL v1
SPL
SPL Set ID a682cd2b-4fb0-3a75-e053-2995a90a5adb
Route
TOPICAL
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Fd&c Yellow No. 5 Ultramarine Blue Aminomethylpropanol Fd&c Blue No. 1 Hypromellose, Unspecified .alpha.-lactose Sucrose Maltodextrin Aloe Vera Leaf Propylene Glycol Water Glycerin Carbomer Interpolymer Type A (55000 Cps) .alpha.-tocopherol Acetate Starch, Corn Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-26

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Indications and Usage

Uses Decrease bacteria on hands

Dosage and Administration

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Description

Active Ingredient Ethyl Alcohol 62%

Section 44425-7

Storage: Flammable,Avoid direct sunlight and keep away from fire.

Section 50565-1

Keep it out of reach of children.

Section 50566-9

Stop use and ask a doctor if irritation or redness develop.If swallowed,get medical help or contact a doctor right away.

Section 51727-6

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Tocopheryl Acetate, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Maltodextrin, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays(Corn)Starch, Hydroxypropyl MethylCellulose, Ultramarines(CI 77007), FD&C Yellow No.5(Cl 19140), FD&C Blue No.1(Cl 42090).

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Uses Decrease bacteria on hands

Dosage and Administration (34068-7)

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Warnings and Precautions (34071-1)

Warnings For external use only.

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Section 44425-7 (44425-7)

Storage: Flammable,Avoid direct sunlight and keep away from fire.

Section 50565-1 (50565-1)

Keep it out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop.If swallowed,get medical help or contact a doctor right away.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Tocopheryl Acetate, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Maltodextrin, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays(Corn)Starch, Hydroxypropyl MethylCellulose, Ultramarines(CI 77007), FD&C Yellow No.5(Cl 19140), FD&C Blue No.1(Cl 42090).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)