Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fd2aedd4-1fae-43b3-8a53-3effe38212c8
Route
TOPICAL
Published
Effective Date 2012-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Water Cetrimonium Chloride Laurtrimonium Chloride Dihydroxyethyl Cocamine Oxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-22

Description

Active Ingredient Benzalkonium Chloride 0.1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use hand sanitizer to reduce bacteria on the skin.

Dosage and Administration

Directions

Place enough product in palm to thoroughly cover all surfaces of both hands

Rub hands together briskly until dry

No rinsing required

Description

Active Ingredient Benzalkonium Chloride 0.1%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Section 51727-6

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

Section 51945-4

Ultracare

For Hands

Alcohol Free Antiseptic Handwash

Formulated to reduce the number of germs on the hands that can cause infection and illness.

Use on clean, non-soiled hands any time when rinsing with water is not available.

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere.

Manufactured for

Ultronics

Cuyahoga Falls, OH 44223

www.UltronicsUSA.com  Tel. (800) 262-6262

1000 ml  33.8 fl. oz.  Made in USA  P/N

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Use hand sanitizer to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions

Place enough product in palm to thoroughly cover all surfaces of both hands

Rub hands together briskly until dry

No rinsing required

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

Section 51945-4 (51945-4)

Ultracare

For Hands

Alcohol Free Antiseptic Handwash

Formulated to reduce the number of germs on the hands that can cause infection and illness.

Use on clean, non-soiled hands any time when rinsing with water is not available.

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere.

Manufactured for

Ultronics

Cuyahoga Falls, OH 44223

www.UltronicsUSA.com  Tel. (800) 262-6262

1000 ml  33.8 fl. oz.  Made in USA  P/N

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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