Label: RECOVERY ANTISEPTIC SKIN PREP- chloroxylenol lotion

  • NDC Code(s): 49436-377-30
  • Packager: PURKLENZ FORMULATIONS INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient: Chloroxylenol 3%

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Uses: Antiseptic cleanser.

    Decreases harmful bacteria or germs.

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY.

    DO NOT INGEST.

    When using this product: Do not use in

    or near the eyes and mouth (oral mucosa). In

    case of eye contact, flush eyes with water.

    Do not use if: you are allergic or sensitive to any of the listed ingredients.

    Stop use and ask doctor if: Irritation, rash, or other allergic reaction occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply as needed and scrub thoroughly for at least 30 seconds. Rinse well and repeat. For best results, do not dilute.

    Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

  • OTHER SAFETY INFORMATION

    Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2

  • Principal Display Package Labeling

    RECOVERY
    ANTISEPTIC
    SKIN PREP

    VEGAN-FRIENDLY
    FREE OF ALCOHOL, PARABENS,
    FRAGRANCES & DYES

    30 FL. OZ. (900 mL)

    NDC: 49436-377-30

    recoveryaftercare.com
    @recoveryaftercare

    Distributed by
    Recovery Aftercare, Inc.
    Hanover, MD 21076

    Made in Canada
    ©Recovery Aftercare, Inc. 2020


    49436-377 900mL

    res

  • INGREDIENTS AND APPEARANCE
    RECOVERY ANTISEPTIC SKIN PREP 
    chloroxylenol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49436-377
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49436-377-30900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/26/2020
    Labeler - PURKLENZ FORMULATIONS INC. (078444179)
    Registrant - PURKLENZ FORMULATIONS INC. (078444179)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK Kolmar Canada, Inc243501959manufacture(49436-377)
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