Label: H-AGE SPOTS FORMULA- thuja occidentalis oil

  • NDC Code(s): 61077-133-11, 61077-133-33
  • Packager: Healing Natural Oils LLC
  • 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 27, 2017

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  • Active Ingredients:

    Thuja occidentalis 12C HPUS

  • Purpose

    Thuja occidentalis 12C HPUS (Dry skin, with brown spots.  Brown spots on hands and arms)

    The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States

  • Inactive Ingredients:

    Corylus avellana nut oil, Essential Oil Blend (Citrus limonum peel, Daucus carota seed, Lavandula officinalis flower bud), Rosa mosqueta
    seed oil, sesamum indicum seed oil.

  • Indications:

    For the appearance of brown spots.

  • Directions:

    Adults and Children 4 years and over:  Wash hands before and after use. Shake well and apply 1 or 2 drops to a cotton swab and dab directly to spots 3x daily. Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.
    Perform skin test prior to initial use.

    Do not use if pregnant or breastfeeding.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control
    Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    H-Age Spots
    Formula

    Homeopathic

    For External Use Only

    133

    11ml (0.37 fl. oz)

    amolis.com

    Age Spots Label

  • INGREDIENTS AND APPEARANCE
    H-AGE SPOTS FORMULA 
    thuja occidentalis oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG) 12 [hp_C]  in 11 mL
    LEMON JUICE (UNII: AGN709ANTJ)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-133-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/29/2014
    2NDC:61077-133-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/29/2014
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-133)
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