Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 72b20188-835b-4f33-863d-40035b7e1e6e
Route
TOPICAL
Published
Effective Date 2011-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mL)
Inactive Ingredients
Water Propylene Glycol Aloe Vera Leaf Cocamidopropyl Betaine Lauramine Oxide Edetate Sodium Methylchloroisothiazolinone Methylisothiazolinone Magnesium Nitrate Magnesium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-08-15

Description

Active ingredient Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For hand sanitizing to reduce bacteria on the skin

Dosage and Administration

Directions

Apply one shot to dry hands, rub into skin

No rinsing required

Description

Active ingredient Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

Section 51945-4

Hy5 Alcohol Free Hand Sanitizer

Alcohol Free Fragrance Free Foaming Hand Sanitizer

55833

Manufactured for

DermaCare, Inc.

P.O. Box 25263, Sarasota, FL  34277

Ph:  1-877-hy5-5678

www.hy5sanitizer.com

1200 mL 40.6 Fluid Ounces

Rev. 08-11

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses

For hand sanitizing to reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

Apply one shot to dry hands, rub into skin

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 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, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

Section 51945-4 (51945-4)

Hy5 Alcohol Free Hand Sanitizer

Alcohol Free Fragrance Free Foaming Hand Sanitizer

55833

Manufactured for

DermaCare, Inc.

P.O. Box 25263, Sarasota, FL  34277

Ph:  1-877-hy5-5678

www.hy5sanitizer.com

1200 mL 40.6 Fluid Ounces

Rev. 08-11

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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