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SPL v4
SPL
SPL Set ID 5f9521f2-53f2-4d7e-9116-36e94e2d0695
Route
TOPICAL
Published
Effective Date 2025-05-14
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 2023-06-29

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Adverse Reactions

INDEPENDANTLY TESTED • SATISFACTION GUARANTEED If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Distributed by: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087


Medication Information

Purpose

Antibacterial

Adverse Reactions

INDEPENDANTLY TESTED • SATISFACTION GUARANTEED

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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
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 Display Panel

Premier Value ®

Foaming

Hand Wash

antibacterial

Fresh scent

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

7.5 FL OZ (221 mL)

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

Antibacterial

Warnings

For external use only: hands only

Directions
  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Adverse Reactions (Adverse reactions)

INDEPENDANTLY TESTED • SATISFACTION GUARANTEED

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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 Display Panel (Principal display panel)

Premier Value ®

Foaming

Hand Wash

antibacterial

Fresh scent

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

7.5 FL OZ (221 mL)

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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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