SPL v1
SPL
SPL Set ID 2ed6cf01-01b4-04af-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Ultramarine Blue Aminomethyl Propanediol Lactose Cellulose, Microcrystalline Sucrose Starch, Corn Alpha-tocopherol Acetate Hypromelloses Fd&c Blue No. 1 Fd&c Yellow No. 5 D&c Red No. 33 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-24

Description

Active Ingredient: Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Indications and Usage

Use To help reduce bacteria on the skin

Dosage and Administration

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

Description

Active Ingredient: Ethyl Alcohol 62%

Section 44425-7

Other Information: Store below 118 F.

Section 50565-1

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

Section 50566-9

Stop use and ask for a doctor if irritation or rash appears and lasts.

Section 51727-6

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

Section 51945-4

Section 55105-1

Purpose Antiseptic

Section 55106-9

Active Ingredient:

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Use To help reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions:

Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Section 44425-7 (44425-7)

Other Information: Store below 118 F.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask for a doctor if irritation or rash appears and lasts.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

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)