Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e413c4a6-c372-4ea2-801f-423b626e7504
Route
TOPICAL
Published
Effective Date 2013-03-13
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 Glycereth-17 Cocoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-10

Description

Active ingredient Benzalkonium Chloride 0.1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Dosage and Administration

Directions

Wash hands with soap and water

Rinse with potable water

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

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 eyes with water.

Section 51727-6

Inactive ingredients

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

Section 51945-4

4 SURE Plus E3 Instant Foam Hand Sanitizer

Hand Sanitizer

Alcohol Free

Kills up to 99.9%

of germs on Hands

Refreshing and Soft on Skin

Acceptable for use in food processing facilities

NSF

Nonfood Compounds

Program Listed E3

#147444

550 mL (18.6 fl. oz) Made in the U.S.A.



Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

Wash hands with soap and water

Rinse with potable water

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

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 eyes 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)

4 SURE Plus E3 Instant Foam Hand Sanitizer

Hand Sanitizer

Alcohol Free

Kills up to 99.9%

of germs on Hands

Refreshing and Soft on Skin

Acceptable for use in food processing facilities

NSF

Nonfood Compounds

Program Listed E3

#147444

550 mL (18.6 fl. oz) Made in the U.S.A.



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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