Label: ELROSELABS- conzerol 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 16, 2015

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  • PURPOSE

    Topical Use for

    Homeopathic treatment for Molluscum Contagiosum

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    SILICEA

    CALCAREA CARBONICA

    THUJA OIL

    NATRUM MURIATICUM

    KALI BROMATUM

    SULPHUR

    KALI MURIATICUM

  • INACTIVE INGREDIENT

    CROTON LECHLERI RESIN
    EMULSIFYING WAX NF
    POLYSORBATE 60
    MAGNESIUM SULFATE, UNSPECIFIED
    VEGETABLE GLYCERIN
    ZINC OXIDE
    DIMETHYL ISOSORBIDE
    TEA TREE OIL
    METHYL SALICYLATE
    CLOVE OIL
    MELISSA OFFICINALIS
    OREGANO LEAF OIL
    CEDRUS ATLANTICA BARK OIL
    NIAOULI OIL
    EUCALYPTUS CAMALDULENSIS LEAF OIL
    COCONUT OIL

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    Clean infected skin area'.

    Apply small amount (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.

  • INDICATIONS & USAGE

    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 or animal bites or burns.

    Stop use and ask doctor if rash or allergic reaction occurs / condition worsens.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed induce vomit.

  • OTHER SAFETY INFORMATION

    Store below 30°c (86°f)

    Do not freeze or refrigerate.

    Discard 6 month after opening.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ELROSELABS 
    conzerol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70223-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE6 [hp_X]  in 30 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 [hp_X]  in 30 g
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE6 [hp_X]  in 30 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]  in 30 g
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [hp_C]  in 30 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CLOVE OIL (UNII: 578389D6D0)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    NIAOULI OIL (UNII: D50IC2T8FU)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70223-001-011 g in 1 CARTON; Type 0: Not a Combination Product01/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/10/2015
    Labeler - Elroselabs Inc. (079977784)
    Registrant - Elroselabs Inc. (079977784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elroselabs Inc.079977784manufacture(70223-001)
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