SPL v1
SPL
SPL Set ID 5ce39b09-3c23-4a22-bb2a-588f9e58ffd2
Route
TOPICAL
Published
Effective Date 2011-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mL)
Inactive Ingredients
Water Alpha-tocopherol Acetate Polysorbate 20 Phenoxyethanol Methylparaben Ethylparaben Propylparaben Butylparaben Isobutylparaben Polyaminopropyl Biguanide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-01-01

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses

For Sanitizing to decrease bacteria on the skin,  safe for repeated use

Warning

For external use only.  When using this product avoid contact with the eyes.  If in eyes flush with water.  Do not ingest.   Discontinue use and contact a doctor if irritation and redness develop and if conditions persist for more than 72 hours.

Directions

Place a small amount on skin and rub until dry. 

Package Label

Steiro Lotion  Kills Germs  A Total Hand / Skin Sanitizer  Foam Hand / Skin Sanitizer Alcohol and Fragrance Free  Moisturizing and conditioning formula  Net Contents: 210 ml/7.1 fl.oz.

Manufactured for Bioblockade LLC  Houma, LA 70364

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 110 degrees F (43 C)  store in an area inaccessible to children.

Inactive Ingredients

Water, Tocopheryl Acetate, Polysorbate 20, Polyaminopropyl Biguanide, Phenooxythanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, and Isobutylparaben

Keep Out of Reach of Children

Children under 6 years of age should be supervised when using this product.


Structured Label Content

Uses

For Sanitizing to decrease bacteria on the skin,  safe for repeated use

Purpose

Antimicrobial

Warning

For external use only.  When using this product avoid contact with the eyes.  If in eyes flush with water.  Do not ingest.   Discontinue use and contact a doctor if irritation and redness develop and if conditions persist for more than 72 hours.

Directions

Place a small amount on skin and rub until dry. 

Package Label

Steiro Lotion  Kills Germs  A Total Hand / Skin Sanitizer  Foam Hand / Skin Sanitizer Alcohol and Fragrance Free  Moisturizing and conditioning formula  Net Contents: 210 ml/7.1 fl.oz.

Manufactured for Bioblockade LLC  Houma, LA 70364

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 110 degrees F (43 C)  store in an area inaccessible to children.

Inactive Ingredients

Water, Tocopheryl Acetate, Polysorbate 20, Polyaminopropyl Biguanide, Phenooxythanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, and Isobutylparaben

Keep Out of Reach of Children

Children under 6 years of age should be supervised when using this product.


Advanced Ingredient Data


Raw Label Data

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