WOUND HEALING (CALENDULA OFFICINALIS) CREAM [ACTIVE RELEASE TECHNIQUES]

WOUND HEALING (CALENDULA OFFICINALIS) CREAM [ACTIVE RELEASE TECHNIQUES]
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NDC 76029-003-35
Set ID b4be80a4-c888-44e4-9095-20817daaf7d8
Category HUMAN OTC DRUG LABEL
Packager Active Release Techniques
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Calendula (Calendula Officinalis)

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Topical relief for:

    • wound healing
    • cuts, scrapes and abrasions
    • minor burns, sunburns
    as per Homeopathic Materia Medica
  • WARNINGS

    for external use only

  • DO NOT USE

    Do not use:

    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
    • this product if you are allergic to any of the ingredients
  • ASK DOCTOR

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

  • STOP USE

    Stop use and ask a doctor:

    • if condition persists or gets worse
    • if a rash or other irritation develops
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a bandage
  • INACTIVE INGREDIENT

    Argania Spinosa Kernel Oil, Betula Alba Bark Extract, Cetearyl Olivate, Chlorphenesin, Citric Acid, Copernicia Cerifera (Carnauba) Wax, Dromiceius, Ethoxydiglycol, Glycerin, Hippophae Rhamnoides Oil, Isopropyl Palmitate, Leptospermum Scoparium Oil, Porphyridium Cruentum Extract, Potassium Citrate, Rutin, Sambucus Nigra Flower Extract, Scrophularia Nodosa Extract, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Water/Aqua, Xanthan Gum

  • QUESTIONS

    Questions or Comments?

    1-888-788-2320 Monday through Friday, 9am-5pm

  • PRINCIPAL DISPLAY PANEL

    • Topical Cream for Wound Healing
    • Natural Active Ingredient
    • Non-Greasy

    Wound Healing Carton


  • INGREDIENTS AND APPEARANCE
    WOUND HEALING  
    calendula officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76029-003
    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 TOP3 [hp_C]  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
    PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    RUTIN (UNII: 5G06TVY3R7)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76029-003-3535 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2011
    Labeler - Active Release Techniques (174462593)
    Registrant - Active Release Techniques (174462593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Leo Desilets maitre herboriste Inc/Facotek Packaging245423439manufacture

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