Atopavo Topical Emusion: Package Insert and Label Information

ATOPAVO TOPICAL EMUSION-
OnPace Pharma LLC

DESCRIPTION

Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns and radiation dermatitis. When applied properly to a wound, Atopavo provides and optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

INDICATIONS AND USAGE

Atopavo is indicated for use in:

  • Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
  • Superficial Wounds
  • 1st and 2nd Degree Burns, including Sunburns
  • Dermal Donor and Graft Site Management
  • Radiation Dermatitis
  • Minor Abrasions

CONTRAINDICATIONS

Atopavo is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known.

WARNINGS

  • In radiation therapy, Atopavo may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session.
  • Do not apply Atopavo to dermal grafts until after the graft has successfully taken.
  • Do not apply to the eyes or to mucous membranes.
  • Not for internal use.
  • Keep out of reach of children.

PRECAUTIONS AND OBSERVATIONS

  • For the treatment of any dermal wound, consult a physician. Use Atopavo only as directed.
  • Atopavo is non-toxic, it is for topical use only and should not be ingested or taken internally.
  • Atopavo does not contain a sunscreen and should not be used prior to extended exposure to the sun.
  • The use of Atopavo on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended.
  • Foloowing the application of Atopavo a temporary tingling sensation may occur (10 to 15 minutes).
  • If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of Atopavo may be continued during the anti-infective therapy.
  • If condition doe not improve within 10-14 days, consult a physician.
  • Atopavo may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE

Atopavo is for topical use only as directed by a healthcare professional.
Wounds, Abrasions, Full Thickness Wounds, Dermal Graft Site Management and Donor Site Management.

  • Wash the affected area(s) with saline, clean water, or a suitable wound cleanser.
  • Apply Atopavo on and around the affected area(s) in thick layers 1/4 to 1/2 inch thick.
  • If applying gauze dressing, moisten the dressing lightly before application.
  • Reapply Atopavo as described above every 24 to 48 hours or as directed until the wound or lesion has healed fully.
  • For donor site management, apply Atopavo after skin removal and cover with a moist dressing. Reapply as directed.
  • For dermal graft site management, apply Atopavo to the graft site only after the graft has taken successfully. Atopavo can be washed away with a saline solution or clean water without causing damage to the newly formed tissues.

1st and 2nd Degree Burns, Including Sunburns

  • Before application of Atopavo to burns, take precaution in removing any clothing in the affected area(s).
  • Apply Atopavo as soon as possible on and around the affected area(s), in a thick 1/4 to 1/2 inch layer until the skin no longer absorbs the product. A white waxy residue may remain. If pain from the burn persists, apply thinner layers of Atopavo until the pain has ceased.
  • Continue to apply Atopavo until the affected area(s) has healed completely.
  • Application of Atopavo to the affected area(s) should continue during any subsequent physical therapy treatments.
Radiation Dermatitis
  • Apply a generous amount of Atopavo three times per day, seven days a week to the treated area(s), gently massaging the area(s) until Atopavo is completely absorbed.
  • Atopavo may be applied as indicated by the treating physician (see WARNINGS).
  • Continue to aply Atopavo as described above until the skin has fully recovered.
  • Do not interrupt applications during the course of radiation therapy, even for one day.
  • Do not apply Atopavo 4 hours prior to a radiation session.

INGREDIENTS

Atopavo contains purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (potassium salt), propylparaben (sodium salt), and fragrance.

HOW SUPPLIED

Atopavo is supplied in a 45-gram tube (60003-52120).

Store at room temperature, do not freeze.

Rx ONLY — Prescription Medical Device: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

Atopavo Label
(click image for full-size original)

ATOPAVO TOPICAL EMUSION
Product Information
Product Type Item Code (Source) GS1:860003521205
Packaging
# Item Code Package Description Multilevel Packaging
1 GS1:860003521205 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (860003521205)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K092878 07/28/2020
Labeler — OnPace Pharma LLC (081039213)

Revised: 07/2020 OnPace Pharma LLC

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