Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID cb9aa943-a23a-78ae-e053-2a95a90af5ff
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Lauramine Oxide Coco Monoethanolamide Lauramidopropylamine Oxide Sodium Chloride Sodium Benzoate Fd&c Blue No. 1 Water Glycerin Cetrimonium Chloride Peg-120 Methyl Glucose Dioleate Fragrance Clean Orc0600327 Citric Acid Monohydrate Edetate Sodium D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-09-01

Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Uses

Helps eliminate bacteria on hands.

Pdp03

Warnings

For external use only

Directions
  • apply onto wet hands
  • Lather and rinse thoroughly
Other Information

Store at Room Temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (Cl 42090), Red 33 (Cl 17200).

When Using This Product

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor.

If irritation or redness develops and lasts

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.


Structured Label Content

Uses

Helps eliminate bacteria on hands.

Pdp03 (PDP03)

Purpose

Antibacterial

Warnings

For external use only

Directions
  • apply onto wet hands
  • Lather and rinse thoroughly
Other Information

Store at Room Temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (Cl 42090), Red 33 (Cl 17200).

When Using This Product (When using this product)

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor. (Stop use and ask a doctor.)

If irritation or redness develops and lasts

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

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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