OTC Medication Information: Hand Wash

HAND WASH- benzalkonium chloride soap
OLD EAST MAIN CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only-hands only

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly 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.

Directions

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

Inactive ingredients

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

adverse reaction section

DISTRIBUTED BY DOLGENCORP, LLC

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GOODLETSVILLE, TN 37072

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STUDIO

SELECTION

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ANTIBACTERIAL

HAND SOAP

With Moisturizers

Paraben Free

11.25 FL OZ (332 mL)

HAND WASH benzalkonium chloride soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-086 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE MYRISTAMIDOPROPYLAMINE OXIDE GLYCERIN DISTEARETH-75 ISOPHORONE DIISOCYANATE PEG-150 DISTEARATE CITRIC ACID MONOHYDRATE EDETATE SODIUM SULISOBENZONE SODIUM BENZOATE FD&C BLUE NO. 1 D&C RED NO. 33

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-086-81 332 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/23/2015

Labeler — OLD EAST MAIN CO. (068331990)

Registrant — Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		088520668	manufacture (55910-086)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		790752542	manufacture (55910-086)

Revised: 05/2022 OLD EAST MAIN CO.