Paveemol-brisas Hand Soap Purple

Paveemol-brisas Hand Soap Purple
SPL v2
SPL
SPL Set ID c5727450-6de4-080a-e053-2995a90a157d
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mg)
Inactive Ingredients
Chlorphenesin .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Panthenol Maltodextrin Polyoxyl 40 Hydrogenated Castor Oil Acrylates Crosspolymer-6 Sodium Benzoate Aloe Vera Leaf Ppg-26-buteth-26 Glycerin Water Cocamidopropyl Betaine Phenoxyethanol Fd&c Yellow No. 5 Fd&c Blue No. 1 Sodium Lauryl Sulfate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-06-20

Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.1%

Use

To help reduce bacteria on hands.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1 800-222-1222

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Warnings

For external use only.

Directions

Apply on hands thoroughly, wash and rinse afterward.

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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15 and 30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Benzalkonium chloride 0.1%

Inactive Ingredients

acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, maltodextrin, panthenol, PEG-40 hydrogenated castor oil, phenoxyethanol, PPG-26-Buteth-26, purified water USP, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, tocopheryl acetate

Package Label Principal Display Panel

250 mL NDC:81892-116-11


Structured Label Content

Use

To help reduce bacteria on hands.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1 800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Purpose

Antiseptic

Warnings

For external use only.

Directions

Apply on hands thoroughly, wash and rinse afterward.

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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15 and 30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Benzalkonium chloride 0.1%

Inactive Ingredients (Inactive ingredients)

acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, maltodextrin, panthenol, PEG-40 hydrogenated castor oil, phenoxyethanol, PPG-26-Buteth-26, purified water USP, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, tocopheryl acetate

Package Label Principal Display Panel (Package Label - Principal Display Panel)

250 mL NDC:81892-116-11


Advanced Ingredient Data


Raw Label Data

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