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Product NDC Code | 10738-054 | ||||||||||
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Drug Name | Triderma eczema fast healing face and body |
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Type | Brand | ||||||||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | CREAM | ||||||||||
RxCUI drug identifier | 1654721 | ||||||||||
Application Number | part347 | ||||||||||
Labeler Name | Genuine Virgin Aloe Corporation | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Colloidal oatmeal 1.5%
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 twice a day or as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier
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 and helps relieve minor skin irritation and itching due to: •eczema •rashes
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.TRIDERMA ECZEMA FAST HEALING FACE AND BODY COLLOIDAL OATMEAL WATER CETOSTEARYL ALCOHOL UREA ISOPROPYL PALMITATE ARNICA MONTANA FLOWER GLYCERIN POLYSORBATE 60 WHITE WAX DIMETHICONE ALLANTOIN ZINC PIDOLATE SODIUM PYRROLIDONE CARBOXYLATE ALOE VERA LEAF PANTHENOL SHEA BUTTER .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM CETYL ALCOHOL PHYTATE SODIUM SODIUM HYDROXIDE PHENOXYETHANOL ETHYLHEXYLGLYCERIN OATMEAL OATMEAL
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.Packaging 4.2 oz carton 4.2 oz tube Eczema Fast Healing Cream_6 oz_Tube_12.15.2020_PRINT
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Temporarily protects & helps relieve minor skin irritation due to eczema & rashes Helps relieve itching AP4 BOTANICAL ALOE VERA COMPLEX with Colloidal Oatmeal Maximum Strength Healing Botanicals Eczema Fast Healing™ cream helps promote fast relief for itching and rashes due to Eczema related symptoms. This rich cream contains essential healing botanicals, vitamins and AP4 ® Aloe Vera Complex. It provides long lasting moisture and helps relieve itching without harmful drugs. Non-Greasy No Added Fragrance or Parabens Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 • AP4® Aloe Vera Complex, a proprietary botanical blend • Colloidal Oatmeal, helps relieve skin irritations due to Eczema and rashes • Shea Butter, Arnica Montana Flower & Beeswax • Vitamins B and E DERMATOLOGIST TESTED Rooted from a medical heritage, TriDerma MD ® was founded after one woman’s struggle to find safe and effective skin healing. At TriDerma MD ® , we strive to create the perfect healing formulations for specific skin irritations. Our products are made using only the finest quality, most effective ingredients. We are passionate in our pursuit of fast healing, natural botanicals that do not cause harmful side effects. Quality you can feel, results you can see. ®
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-279-7282 M-F 8am-4pm PST
Storage and handling
Information about safe storage and handling of the drug product.Other Information •store at room temperature.
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. Do not use •on deep puncture wounds •on infections •on lacerations When using this product •do not get into eyes Stop use and ask a doctor if •condition worsens or does not improve within 7 days 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