Label: PHARMAX HEAL  TRANS-DERMAL WOUND HEALING- calendula officinalis flowering top cream 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/11

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Calendula (Calendula officinalis L.) 3C

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  • PURPOSE

    Antiseptic

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  • INDICATIONS & USAGE

    Uses:
    Topical relief for:

    • wounds
    • cuts, scrapes and abrasions
    • minor burns and sunburns

    as per Homeopathic Materia Medica.

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  • WARNINGS

    For external use only.

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  • STOP USE

    Stop use and ask a doctor if:

    • symptoms persist or worsen
    • a rash or other irritation develops
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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  • INACTIVE INGREDIENT


    Argania spinosa kernel oil, betula alba bark extract, cetearyl olivate, chlorphenesin, citric acid, copernicia cerifera (carnauba) wax, dromiceius oil, ethoxydiglycol, ethylhexylglycerin, glycerin,
    hippophae rhamnoides oil, isopropyl palmitate, leptospermum scoparium oil, porphyridium cruentum extract, potassium citrate, purified water, rutin, sambucus nigra flower extract, scrophularia nodosa extract, sodium hydroxide, sodium phytate, sorbitan olivate, xanthan gum

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  • DOSAGE & ADMINISTRATION

    Directions:

    • clean the affected area
    • apply a small amount on the affected area 1 to 3 times daily or as recommended by a doctor
    • may be covered with a bandage
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  • DO NOT USE

    Do not use:

    • in eyes
    • over large areas of body
    • longer than one week, unless directed by a doctor
    • if you are allergic to the Astereae/Compositae/Daisy family
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  • QUESTIONS

    Questions? 1-888-737-6925

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  • ASK DOCTOR

    Ask a doctor before use if you have deep orpuncture wounds, animal bites or serious burns.

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  • INGREDIENTS AND APPEARANCE
    PHARMAX HEAL   TRANS-DERMAL WOUND HEALING
    calendula cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62106-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C]  in 50 g
    Inactive Ingredients
    Ingredient Name Strength
    ARGAN OIL  
    BETULA PUBESCENS BARK  
    CHLORPHENESIN  
    CITRIC ACID MONOHYDRATE  
    CETEARYL OLIVATE  
    CARNAUBA WAX  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    GLYCERIN  
    ISOPROPYL PALMITATE  
    ETHYLHEXYLGLYCERIN  
    HIPPOPHAE RHAMNOIDES SEED OIL  
    MANUKA OIL  
    POTASSIUM CITRATE  
    WATER  
    PORPHYRIDIUM PURPUREUM  
    RUTIN  
    SAMBUCUS NIGRA FLOWER  
    SODIUM HYDROXIDE  
    SORBITAN OLIVATE  
    XANTHAN GUM  
    SCROPHULARIA NODOSA  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-003-50 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/01/2011
    Labeler - Seroyal USA (018361118)
    Registrant - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Leo Desilets maitre herboriste Inc/Facotek Packaging 245423439 manufacture
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