SPL v1
SPL
SPL Set ID a6e75e18-c361-1241-e053-2995a90a27c7
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) Aminomethylpropanol .alpha.-tocopherol Acetate Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-29

Description

Active Ingredient Ethyl Alcohol 75%


Medication Information

Warnings and Precautions

Warnings: For external use only, Flammable, Keep away from fire or flame

Indications and Usage

Uses: to help reduce germs on the skin

Dosage and Administration

Directions: Squeeze a significant amount in your palm and rub hands until fully dry. Rinse free.

Description

Active Ingredient Ethyl Alcohol 75%

Section 44425-7

Other information: Store below 110︒F(43︒C)

Section 50565-1

Keep out of reach of children: In case of accidental ingetion, get medical help or contact a poison control center immediately.

Section 50566-9

Stop using and ask a doctor: if irritation or redness develops and lasts.

Section 50567-7

When using this product: avoid contact with eyes, if contact occurs, rinse thoroughly with water.

Section 51727-6

Inactive ingredients

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,Denatonium benzoate, Fragrance(Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water(Aqua).

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 75%


Structured Label Content

Indications and Usage (34067-9)

Uses: to help reduce germs on the skin

Dosage and Administration (34068-7)

Directions: Squeeze a significant amount in your palm and rub hands until fully dry. Rinse free.

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 110︒F(43︒C)

Section 50565-1 (50565-1)

Keep out of reach of children: In case of accidental ingetion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor: if irritation or redness develops and lasts.

Section 50567-7 (50567-7)

When using this product: avoid contact with eyes, if contact occurs, rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive ingredients

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,Denatonium benzoate, Fragrance(Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water(Aqua).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 75%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)