Simply U 628.002/628ad-af

Simply U 628.002/628ad-af
SPL v17
SPL
SPL Set ID e368e7b8-9695-4dd8-a49b-8c17c24c7f51
Route
TOPICAL
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Lauramidopropylamine Oxide Lauramine Oxide Myristamidopropylamine Oxide Glycerin Citric Acid Monohydrate Edetate Sodium Sulisobenzone Sodium Benzoate Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-20 Until 2024-04-24

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Adverse Reactions

Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114


Medication Information

Purpose

Antibacterial

Adverse Reactions

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

Description

Benzalkonium chloride 0.13%

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

Directions
  • wet hands
  • apply palmful to dry hands
  • scrub thoroughly
  • rinse thoroughly
Questions?

1-888-593-0593

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

Principal Panel Display

SIMPLY U

ANTIBACTERIAL 

FOAMING 

HAND WASH

REFRESHING SCENT

helps kill harmful germs

refill

32 FL OZ (1 QT) 946 mL

When Using This Product
  • avoid contact with eyes.  If contact occurs, rinse eyes with water.
Stop Use and Ask A Doctor If
  • irritation or redness develops
  • condition persists for more than 72 hours
Keep Out of Reach of Children.

if swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Warnings

For external use only: hands only

Directions
  • wet hands
  • apply palmful to dry hands
  • scrub thoroughly
  • rinse thoroughly
Questions?

1-888-593-0593

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Adverse Reactions (Adverse reactions)

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

Principal Panel Display (Principal panel display)

SIMPLY U

ANTIBACTERIAL 

FOAMING 

HAND WASH

REFRESHING SCENT

helps kill harmful germs

refill

32 FL OZ (1 QT) 946 mL

When Using This Product (When using this product)
  • avoid contact with eyes.  If contact occurs, rinse eyes with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops
  • condition persists for more than 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)

if swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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