Label: REMEDY ANTIMICROBIAL CLEANSER- benzalkonium chloride solution

  • NDC Code(s): 53329-158-04, 53329-158-08, 53329-158-34
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated December 20, 2019

If you are a consumer or patient please visit this version.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for Medline Industries, Inc., Mundelein, IL 60060 www.medline.com 1-800-MEDLINE. Made in USA.

  • Package Label

    Label 158

  • INGREDIENTS AND APPEARANCE
    REMEDY ANTIMICROBIAL CLEANSER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE120 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL (UNII: AKN3KSD11B)  
    MANDARIN OIL (UNII: NJO720F72R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCINE (UNII: TE7660XO1C)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    TAURINE (UNII: 1EQV5MLY3D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-158-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/08/2018
    2NDC:53329-158-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/08/2018
    3NDC:53329-158-34148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2008
    Labeler - Medline Industries, Inc. (025460908)