SPL v1
SPL
SPL Set ID 183935e8-6178-545b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-11

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

Uses: 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.

Section 50566-9

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

Section 51727-6

Inactive ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxypropyl Methyl Cellulose, FD&C Blue NO.1, FD&C Yellow NO.5.

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: 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.

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

Inactive ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxypropyl Methyl Cellulose, FD&C Blue NO.1, FD&C Yellow NO.5.

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)