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| Product NDC Code | 58518-040 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Barrier cream |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Avasol LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide (Non-nano) 10%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Barrier Cream ZINC OXIDE ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES COCONUT OIL YELLOW WAX CANDELILLA WAX JOJOBA OIL TOCOPHEROL OLEA EUROPAEA LEAF ORANGE PEEL WAX ASTAXANTHIN BENTONITE CETEARYL OLIVATE SORBITAN OLIVATE PROPOLIS WAX LAVENDER OIL ROSEMARY ALOE VERA WHOLE ST. JOHN'S WORT CHAMOMILE LICORICE CALENDULA OFFICINALIS FLOWER MANUKA OIL PEPPERMINT OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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) Principal Display Panel - 59 mL Pouch Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect from freezing. Avoid excessive heat.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 888-805-1507 or visit www.avasol.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API