FDA Label for Barrier Cream

View Indications, Usage & Precautions

Barrier Cream Product Label

The following document was submitted to the FDA by the labeler of this product Avasol Llc. 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.

Active Ingredients



Zinc Oxide (Non-nano) 10%


Purpose



Skin protectant


Uses



  • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
  • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Warnings



  • For external use only
  • Avoid contact with eyes. Rinse with water to remove.

Stop Use And Ask A Doctor



  • Condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Otc - Do Not Use



Do not use:

  • if allergic to ingredients.
  • on deep or puncture wounds
  • on animal bites •on serious burns.
  • Test small area first.

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.


Directions



Apply liberally, directly on skin as needed. May be applied to prosthetics, protective equipment, etc. Will solidify at cold temps. Warm and knead as required.


Inactive Ingredients



*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic **Wildcrafted


Other Information



Protect from freezing. Avoid excessive heat.


Questions?



Call 888-805-1507 or visit www.avasol.com


Principal Display Panel - 59 Ml Pouch Label



avasol®

BARRIER
CREAM

BIOBASED

Multipurpose

Anti-chafing

Skin protectant

No Petrochemicals • No Synthetics

2 FL OZ (59 mL)


* Please review the disclaimer below.