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Remedy Antimicrobial Cleanser

Dosage form: solution
Ingredients: BENZALKONIUM CHLORIDE 0.12mL in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-158

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.

Drug Facts

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antimicrobial

Uses

A no-rinse topical antiseptic that protects against microbial contamination

Warnings

For External Use Only.

Do not use
  • in the eyes or apply over large areas of the body.

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product
  • do not use longer than 1 week unless directed by a doctor
  • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if
  • condition worsens or if symptoms persist for more than 7 days and occur again within a few days.

Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Spray soiled and/ or odorous (body and perineal) areas.
  • Gently wipe clean.
  • Repeat as necessary until all soils are removed and skin is clean.
  • Pat dry. No rinsing necessary.
  • Apply a Remedy protectant cream or paste as necessary.

Other information
  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl- L-cysteine, Niacinamide, Polysorbate 20, Propylene Glycol, Propylparaben, Pyridoxine HCl, Tetrasodium EDTA, Vanillin, Water.

Package/Label Principal Display Panel

Remedy Antimicrobial Cleanser

MEDLINE

N 53329-158-08

REMEDY

WITH OLIVAMINE

ANTIMICROBIAL CLEANSER

TARGETED CLEANSING

No-rinse nourishing formula to decrease

bacteria and other microorganisms

NON-ALLERGENIC NON-SENSITIZING

8 fl oz (236 mL)

REMEDY ANTIMICROBIAL CLEANSER 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-158
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ORANGE OIL 
MANDARIN OIL 
DIAZOLIDINYL UREA 
GLYCERIN 
GLYCINE 
PROLINE 
TAURINE 
METHYLPARABEN 
DIMETHYL SULFONE 
ACETYLCYSTEINE 
NIACINAMIDE 
POLYSORBATE 20 
PROPYLENE GLYCOL 
PROPYLPARABEN 
PYRIDOXINE HYDROCHLORIDE 
EDETATE SODIUM 
VANILLIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:53329-158-04118 mL in 1 BOTTLE, SPRAY
2NDC:53329-158-08236 mL in 1 BOTTLE, SPRAY
3NDC:53329-158-34148 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2008
Labeler - Medline Industries, Inc. (025460908)

Revised: 03/2012
Document Id: afbe947b-d3ce-4ce4-a2af-0c8b90adeda7
Set id: bde15cd9-9a93-419f-8da4-9d7b9a1645b4
Version: 3
Effective Time: 20120320
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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