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  5. Label Information: Wound Healing

FDA Label for Wound Healing

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wound Healing Product Label

The following document was submitted to the FDA by the labeler of this product Active Release Techniques. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Calendula (Calendula Officinalis)


Otc - 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


Otc - 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

Otc - Ask Doctor



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


Otc - Stop Use



Stop use and ask a doctor:

  • if condition persists or gets worse
  • if a rash or other irritation develops

Otc - Pregnancy Or Breast Feeding



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


Otc - 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


Otc - Questions



Questions or Comments?

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Package Label.Principal Display Panel



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