Label: NATRALIA ACNE- calendula officinalis flower, calcium carbonate, and pulsatilla vulgaris 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 December 19, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
    Calcarea Carbonica (3× HPUS 0.5%)*Acne Control
    Pulsatilla Vulgaris (3× HPUS 0.5%)*Acne Control
    Calendula Officinalis (6× HPUS 1%)*Acne Control
  • Uses

    • Use on affected areas to clear and prevent breakouts.
    • Suitable for use on the face and body
  • Warnings

    • For External Use Only

    • If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician

    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

    • Keep out of reach of children

    • Avoid unnecessary sun exposure
  • Directions

    • Use morning and night
    • After cleansing with Natralia Acne Wash, cover the entire affected area with a thin layer of Natralia Acne Cream.
  • Other information

    • Store between 50°- 86°F in a dry place.
  • Inactive ingredients

    Capric/Caprylic Triglycerides, Caprylyl Glycol (and) Sorbic Acid (and) Phenoxyethanol, Cetyl Palmitate (and) Sorbitan Palmitate (and) Sorbitan Olivate, Chamomilla Recutita (Chamomile) Extract, Garcinia Mangostana Extract, Glycerine, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer (and) Squalane (and) Polysorbate 60, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Oil, Rosa Canina Fruit (Rose Hip) Oil, Sodium Hydroxide, Stearic Acid, Water, Zinc PCA

  • Questions or comments?

    Call Toll Free 1-877-687-2542

    usainfo@natralia.com.au

    www.natralia.com.au/usa

  • PRINCIPAL DISPLAY PANEL - 56g Bottle Carton

    natralia™
    NATURALLY AUSTRALIAN

    acne cream

    natural homeopathic alternative

    Treat & Control

    • Rapidly clears and
      prevents breakouts
    • Helps improve the
      appearance of scars
      associated with acne
    • Kills 99.8% of acne
      causing bacteria

    Contains 0.5% ethanol w/w

    Net Wt 2 oz (56g)

    PRINCIPAL DISPLAY PANEL - 56g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NATRALIA   ACNE
    calendula officinalis flower, calcium carbonate, and pulsatilla vulgaris cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER6 [hp_X]  in 1 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE3 [hp_X]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Chamomile (UNII: FGL3685T2X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Zinc Pidolate (UNII: C32PQ86DH4)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Sorbitan Monopalmitate (UNII: 77K6Z421KU)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Squalane (UNII: GW89575KF9)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Rosa Canina Fruit Oil (UNII: CR7307M3QZ)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Witch Hazel (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-3333-61 in 1 CARTON
    156 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/01/2009
    Labeler - LaCorium Health International Pty Ltd (758651624)
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