183935e8-6178-545b-e054-00144ff8d46c

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.

Active Ingredient

Active Ingredient:

Ethyl Alcohol 62%.

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Flammable. Keep away from fire or flame.

Active Ingredient (55106-9)

Active Ingredient:

Ethyl Alcohol 62%.

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.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)