SPL v4
SPL
SPL Set ID f77b928e-ac33-4501-be21-9f4061af3e36
Route
TOPICAL
Published
Effective Date 2021-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Water Methylchloroisothiazolinone Glycerin Methylisothiazolinone Cetrimonium Chloride Lauramidopropylamine Oxide Coco Monoethanolamide Propylene Glycol Citric Acid Monohydrate Phenoxyethanol Edetate Sodium Sodium Chloride Decyl Glucoside Coco Glucoside Glyceryl Oleate Cocamidopropyl Betaine Lauramine Oxide Behentrimonium Chloride Peg-7 Glyceryl Cocoate Cocamidopropyl Hydroxysultaine Polysorbate 20 Peg-12 Dimethicone Fd&c Blue No. 1 Fragrance Fresh Citrus Floral Orc1501495

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-23 Until 2021-04-23

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

Helps eliminate bacteria on hands.

Directions

• Wet hands and wrists with clean running water.

• Apply appropriate amount of product.

• Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly.

• Rinse thoroughly with running water.

• Dry hands completely.

Drug Facts

Warnings 

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Product Label

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

• Store below 104°F (40°C)

Inactive Ingredient

Water,Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, Propylene Glycol,Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide,Behentrimonium Chloride, PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Polysorbate 20, Sodium Chloride, PEG-12 Dimethicone , FD&C Blue NO. 1, Fragrance Fresh Citrus Floral ORC1501495.

Keep Out of Reach of Children 

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions

• Wet hands and wrists with clean running water.

• Apply appropriate amount of product.

• Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly.

• Rinse thoroughly with running water.

• Dry hands completely.

Drug Facts

Warnings 

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)

• Store below 104°F (40°C)

Inactive Ingredient (Inactive ingredient)

Water,Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, Propylene Glycol,Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide,Behentrimonium Chloride, PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Polysorbate 20, Sodium Chloride, PEG-12 Dimethicone , FD&C Blue NO. 1, Fragrance Fresh Citrus Floral ORC1501495.

Keep Out of Reach of Children  (Keep out of reach of children )

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)