Studio Selection 628.002/628af

Studio Selection 628.002/628af
SPL v22
SPL
SPL Set ID 29e5da06-8897-4a79-8eea-f359ba0bdf78
Route
TOPICAL
Published
Effective Date 2025-12-26
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 2016-02-17

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

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 hands
  • scrub thoroughly 
  • rinse thoroughly
Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN C0

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFATION GUARANTEED (888)309-9030

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

When Using This Product
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel

Studio Selection ®

antibacterial

FOAMING HAND SOAP

Helps kill harmful germs

fresh spring

7.5 FL OZ (221 mL)

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • 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 (purpose)

Antibacterial

Warnings

For external use only: hands only

Directions
  • wet hands
  • apply palmful to hands
  • scrub thoroughly 
  • rinse thoroughly
Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY OLD EAST MAIN C0

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFATION GUARANTEED (888)309-9030

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

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

When Using This Product (When using this product)
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel (principal display panel)

Studio Selection ®

antibacterial

FOAMING HAND SOAP

Helps kill harmful germs

fresh spring

7.5 FL OZ (221 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • 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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