Label: MOLLEAVE- lemon balm oil cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 20, 2020

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  • Active Ingredients

    Active Ingredient Purpose

    Lemon balm oil 1x............................................MCV Relief

  • Purpose

    Purpose

    MCV Relief

  • Use

    Use

    • Molluscum Contagiosum lesion relief.
  • Warnings

    Warnings

    • For external use only
    • Do not use on large areas of the body, wounds, punctured skin, in eyes, animal bites or burns.
    • Stop use and ask doctor if rash or allergic reaction occurs/Condition worsens.
    • If swallowed induce vomiting, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

    Keep out of reach of children.

  • Directions

    Directions

    • Clean infected skin area.
    • Apply small aount (equal to lesion size) on each lesion.
    • Gently rub in circular motion leaving thin cream layer.
    • Repeat treatment 2 to 3 times daily.
    • Let dry for 3 minutes.
  • Other Information

    Other Information

    • Store below 30 degrees C (86 degrees F)
    • Do not freeze or refrigerate
    • Discard six months after opening
    • May stain fabrics and surfaces
  • Inactive Ingredients

    Inactive Ingredients Caprylyl Glycol, Clove oil, Croton lechleri, Lemon grass oil, phenoxyethanol, sorbic acid, tea tree oil, thuja occidentalis

  • Inactive Ingredients

    Inactive Ingredients Caprylyl Glycol, Clove oil, Croton lechleri, Lemon grass oil, phenoxyethanol, sorbic acid, tea tree oil, thuja occidentalis

  • PDP

    Label

  • INGREDIENTS AND APPEARANCE
    MOLLEAVE 
    lemon balm oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73576-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEMON BALM OIL (UNII: MJ76269K9S) (LEMON BALM OIL - UNII:MJ76269K9S) LEMON BALM OIL1 [hp_X]  in 22 g
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    SORBIC ACID (UNII: X045WJ989B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73576-001-001 in 1 BOX02/05/2020
    1NDC:73576-001-0122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/05/2020
    Labeler - Innovative Med (536425210)
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