SPL v4
SPL
SPL Set ID ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
Route
TOPICAL
Published
Effective Date 2021-03-09
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 Edetate Sodium Decyl Glucoside Coco Glucoside Glyceryl Oleate Cocamidopropyl Betaine Behentrimonium Chloride Peg-7 Glyceryl Cocoate Polysorbate 20 Peg-12 Dimethicone (300 Cst) Aloe Vera Leaf Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-10 Until 2021-03-10

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

 Helps eliminate bacteria on hands.

Section 51945-4

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.

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

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

• Store below 104°F (40°C)

Inactive Ingredients

Water ( Aqua), Caprylyl Glycol, Coco Glucoside, Decyl Glucoside, PEG-12 Dimethicone, 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, Edetate Sodium.

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.

Section 51945-4 (51945-4)

Purpose

Antibacterial

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.

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

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)

• Store below 104°F (40°C)

Inactive Ingredients (Inactive ingredients)

Water ( Aqua), Caprylyl Glycol, Coco Glucoside, Decyl Glucoside, PEG-12 Dimethicone, 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, Edetate Sodium.

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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