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| Product NDC Code | 10738-069 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Triderma baby stubborn eczema itch relief |
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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 Aloe Virgin Corporation | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 BABY STUBBORN ECZEMA ITCH RELIEF Colloidal Oatmeal WATER CETOSTEARYL ALCOHOL UREA ISOPROPYL PALMITATE ARNICA MONTANA FLOWER GLYCERIN POLYSORBATE 60 YELLOW 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 Helps relieve minor skin irritation & itching due to eczema & rashes Dermatologist Tested Colloidal Oatmeal Skin Protectant This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes. It provides long-lasting moisture and powerful, yet gentle, itch relief. Enriched with essential botanicals, AP4 ® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides soothing relief for all ages. AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend Colloidal Oats - helps soothe & relieve itching, rashes & eczema Arnica Montana - known to help soothe irritated skin Shea Butter - soothes & moisturizes Vitamins, Beeswax, Allantoin & Zinc PCA For healthier skin, also try: Eczema Itch Relief Wash & Shampoo Healing All Purpose Cream Daily Calming™ Moisturizer Maximum Strength Healing Botanicals Stubborn Eczema Itch™ Relief Cream provides the special care needed to help protect sensitive skin against dryness, rashes and eczema related symptoms that can appear anywhere on the body. Works quickly Soothes, moisturizes & protects Powerful itch relief Clinically Tested, Safe for Sensitive Skin Non-Greasy • No Added Fragrance Free from Cortisone, Steroids & Parabens EXPERTS IN SKIN HEALING SINCE 1992 TriDerma MD ® provides healing solutions for irritated skin without harmful side effects. It all began after one woman struggled to find safe and effective healing for her own skin problem. This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products. QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ® Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients. We are passionate in our pursuit to create fast healing products that work. Learn More at www.triderma.com MADE IN THE USA Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 Label
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
Helps relieve minor skin irritation & itching due to eczema & rashes Dermatologist Tested Colloidal Oatmeal Skin Protectant This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes. It provides long-lasting moisture and powerful, yet gentle, itch relief. Enriched with essential botanicals, AP4 ® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides soothing relief for all ages. AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend Colloidal Oats - helps soothe & relieve itching, rashes & eczema Arnica Montana - known to help soothe irritated skin Shea Butter - soothes & moisturizes Vitamins, Beeswax, Allantoin & Zinc PCA For healthier skin, also try: Eczema Itch Relief Wash & Shampoo Healing All Purpose Cream Daily Calming™ Moisturizer Maximum Strength Healing Botanicals Stubborn Eczema Itch™ Relief Cream provides the special care needed to help protect sensitive skin against dryness, rashes and eczema related symptoms that can appear anywhere on the body. Works quickly Soothes, moisturizes & protects Powerful itch relief Clinically Tested, Safe for Sensitive Skin Non-Greasy • No Added Fragrance Free from Cortisone, Steroids & Parabens EXPERTS IN SKIN HEALING SINCE 1992 TriDerma MD ® provides healing solutions for irritated skin without harmful side effects. It all began after one woman struggled to find safe and effective healing for her own skin problem. This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products. QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ® Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients. We are passionate in our pursuit to create fast healing products that work. Learn More at www.triderma.com MADE IN THE USA Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879
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 • keep carton for important information.
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 •avoid contact with eyes. If contact occurs, rinse thoroughly with water. 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