Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0f01336e-ab47-4a9a-a741-647b780717f3
Route
TOPICAL
Published
Effective Date 2015-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Caprylyl Glycol Glycerin Isopropyl Alcohol Isopropyl Myristate Polyoxyl 40 Hydrogenated Castor Oil Phenoxyethanol Propylene Glycol Alpha-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-02-05

Description

Active ingredient Ethyl Alcohol 62% v/v


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses • hand sanitizer to help reduce bacteria on the skin, when water, soap and towel are not available. • recommended for repeated use.

Dosage and Administration

Directions •Pump as needed into your palm to thoroughly spread on both hands. •rub into the skin until dry.

Description

Active ingredient Ethyl Alcohol 62% v/v

Section 42229-5

Other Information • store at 20°C(68-77°F). • May discolor fabrics.

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50567-7

When using this product • avoid contact with eyes • in case of eye contact flush eyes with water. • stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Section 51727-6

Inactive ingredients caprylyl glycol, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, tocopheryl acetate, triethanolamine, water.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Ethyl Alcohol 62% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses • hand sanitizer to help reduce bacteria on the skin, when water, soap and towel are not available. • recommended for repeated use.

Dosage and Administration (34068-7)

Directions •Pump as needed into your palm to thoroughly spread on both hands. •rub into the skin until dry.

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Other Information • store at 20°C(68-77°F). • May discolor fabrics.

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50567-7 (50567-7)

When using this product • avoid contact with eyes • in case of eye contact flush eyes with water. • stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Section 51727-6 (51727-6)

Inactive ingredients caprylyl glycol, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, tocopheryl acetate, triethanolamine, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Ethyl Alcohol 62% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)