Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 353aeb2b-a653-4826-99cc-43663e16a006
Route
TOPICAL
Published
Effective Date 2013-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 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 2013-10-23

Description

Active ingredient Ethyl Alcohol 70% 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. • recommended for repeated use

Dosage and Administration

Directions •place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry • recommended for repeated use.

Description

Active ingredient Ethyl Alcohol 70% v/v

Section 42229-5

Other Information •do not store above 105F. May discolor some fabrics • harmful to wood finishes and plastics

Section 50565-1

Keep out of reach of children. Children should only use this product under adult supervision.

Do not drink. Not edible in case of accidental ingestion seek professional assistance or contact a Poison Control Center right away.

Section 50567-7

When using this product • avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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 70% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses • hand sanitizer to help reduce bacteria on the skin. • recommended for repeated use

Dosage and Administration (34068-7)

Directions •place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry • recommended for repeated use.

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Other Information •do not store above 105F. May discolor some fabrics • harmful to wood finishes and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. Children should only use this product under adult supervision.

Do not drink. Not edible in case of accidental ingestion seek professional assistance or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product • avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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 70% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)