Wound Healing
FDA Label NDC 76029-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Active Release Techniques for the product Wound Healing (NDC 76029-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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?

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

Package Label.Principal Display Panel

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

    • Wound Healing Carton (Woundhealingcarton)

    Wound Healing Carton (Woundhealingcarton)



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