drug facts

drug facts
SPL v1
SPL
SPL Set ID 86dfc5b3-768a-4d7b-9911-6a3f0cb00413
Route
topical
Published
Effective Date 2021-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (130 mg)
Inactive Ingredients
water lauramidopropylamine oxide glycerin cetrimonium chloride sodium chloride coco monoethanolamide peg-120 methyl glucose dioleate fragrance clean orc0600327 citric acid monohydrate edetate sodium sodium sulfate methylchloroisothiazolinone methylisothiazolinone fd&c red no. 40 fd&c yellow no. 5 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-07-13

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)


Medication Information

Warnings

For external use only 

Uses

Helps eliminate bacteria on hands

Purpose

Antibacterial

Directions
  • use to refill a hand soap pump bottle.
  • From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Description

Benzalkonium Chloride (0.13%)

Pdp04

Active Ingredient.

Benzalkonium Chloride (0.13%)

Questions Or Comments ?

1-800-925-4733

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 a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only 

Uses

Helps eliminate bacteria on hands

Purpose

Antibacterial

Directions
  • use to refill a hand soap pump bottle.
  • From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Pdp04 (PDP04)

Active Ingredient.

Benzalkonium Chloride (0.13%)

Questions Or Comments ? (Questions or comments ?)

1-800-925-4733

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 a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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