H-FISSURES FORMULA (CALENDULA OFFICINALIS, CHAMOMILLA) OIL [HEALING NATURAL OILS LLC]

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H-FISSURES FORMULA (CALENDULA OFFICINALIS, CHAMOMILLA) OIL [HEALING NATURAL OILS LLC]
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NDC 61077-036-11, 61077-036-33
Set ID aa2b25cc-5bf3-4aee-951f-497b8ae69f07
Category HUMAN OTC DRUG LABEL
Packager Healing Natural Oils LLC
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredients:

    Calendula officinalis -12C HPUS   
    Chamomilla - 6C HPUS

  • Purpose

    Calendula officinalis - 12C HPUS (healing agent),
    Chamomilla - 6C HPUS (soreness of anus, painful fissures).

    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 (Helichrysum
    italicum flower, Lavandula officinalis flower
    bud, Matricaria recutita flower)

  • Indications:

    For the temporary relief of anal fissure symptoms such as burning, soreness and minor bleeding.

  • Directions:

    Adults and Children 4 yrs and over:  Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
    Do not oversaturate or exceed dosage.

  • Warnings:

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

    If pregnant or breastfeeding consult a doctor before use.


    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-Fissures

    Formula

    Homeopathic

    For External Use Only

    036

    11ml (0.37 fl. oz)
    amoils.com

    Fissures Label

  • INGREDIENTS AND APPEARANCE
    H-FISSURES FORMULA  
    calendula officinalis, chamomilla oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_C]  in 11 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ( MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-036-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-036-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio, Inc.617901350manufacture(61077-036)
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