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

Adverse Reactions

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

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings

For external use only: hands only

Purpose

Antibacterial

Directions
  • wet hands
  • apply palmful to dry hands
  • scrub thoroughly
  • rinse thoroughly
Adverse Reactions

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

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

Description

Benzalkonium chloride 0.13%

Questions?

1-888-593-0593

Use

for handwashing to decrease bacteria on the skin

Active Ingredient

Benzalkonium chloride 0.13%

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

Warnings

For external use only: hands only

Purpose

Antibacterial

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

Questions?

1-888-593-0593

Use

for handwashing to decrease bacteria on the skin

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

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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