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

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STUDIO

SELECTION

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ANTIBACTERIAL

HAND SOAP

With Moisturizers

Paraben Free

11.25 FL OZ (332 mL)

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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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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