SPL v3
SPL
SPL Set ID 3b0dd1a0-9b27-461e-ac50-2120d3912dce
Route
TOPICAL
Published
Effective Date 2021-11-03
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 Caprylyl Glycol Propylene Glycol Citric Acid Monohydrate Phenoxyethanol Decyl Glucoside Coco Glucoside Glyceryl Oleate Cocamidopropyl Betaine Behentrimonium Chloride Peg-7 Glyceryl Cocoate Fragrance Floral Orc0902236 Betaine Aloe Vera Leaf Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-27 Until 2021-04-27

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

Helps eliminate bacteria on hands.

Directions

• Put enough product in your palm to cover hands and rub hands together briskly for 30 seconds. Allow to dry.

• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

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 ( Aqua), Caprylyl Glycol, Coco Glucoside, Decyl Glucoside, Cocoamidopropyl Betaine, Methylisothiozolinone, Methylchloro Isothiozolinone, Phenoxy Ethanol, Cetrimonium Chloride, Behentrimonium Chloride, Aloevera Leaf, PEG-7 Glyceril Cocoate, Betain, Polysorbate 20, Citric Acid, Glyceril Oleate , Glycerin, Propylene Glycol, Fragrance Floral ORC0902236.

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

• Put enough product in your palm to cover hands and rub hands together briskly for 30 seconds. Allow to dry.

• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

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 ( Aqua), Caprylyl Glycol, Coco Glucoside, Decyl Glucoside, Cocoamidopropyl Betaine, Methylisothiozolinone, Methylchloro Isothiozolinone, Phenoxy Ethanol, Cetrimonium Chloride, Behentrimonium Chloride, Aloevera Leaf, PEG-7 Glyceril Cocoate, Betain, Polysorbate 20, Citric Acid, Glyceril Oleate , Glycerin, Propylene Glycol, Fragrance Floral ORC0902236.

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

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