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| Product NDC Code | 10738-205 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema fast healing body wash |
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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 | LOTION/SHAMPOO | ||||
| RxCUI drug identifier | 2396990 | ||||
| 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 Dispense a dime to quarter-sized amount into palm, gently massage onto wet skin. Rinse. For extra cleansing, allow to sit for 30 seconds and then rinse.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredients water, sodium C14-16 olefin sulfonate, cocamidopropyl hydroxysultaine, cocamide MIPA, hydroxypropyl bis-hydroxyethyldimonium chloride, aloe barbadensis leaf juice, cannabis sativa seed oil, citric acid, glycerin, hedera helix (ivy) leaf extract, arnica montana flower extract, sambucus nigra flower extract, malva sylvestris (mallow) flower extract, tilia platyphyllos flower extract, cucumis sativus (cucumber) fruit, parietaria officinalis extract, triticum vulgare (wheat) germ oil, allantoin, bisabolol, tocopheryl acetate (vitamin E), sodium benzoate, potassium sorbate.
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 •poison ivy •insect bites
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.Eczema Fast Healing Body Wash Colloidal Oatmeal COCO MONOISOPROPANOLAMIDE HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE CANNABIS SATIVA SEED OIL GLYCERIN HEDERA HELIX LEAF ARNICA MONTANA FLOWER SAMBUCUS NIGRA FLOWER SODIUM C14-16 OLEFIN SULFONATE MALVA SYLVESTRIS FLOWER TILIA PLATYPHYLLOS FLOWER ALOE VERA LEAF CUCUMBER PARIETARIA OFFICINALIS LEAF WHEAT GERM OIL CITRIC ACID MONOHYDRATE ALLANTOIN LEVOMENOL SODIUM BENZOATE POTASSIUM SORBATE .ALPHA.-TOCOPHEROL ACETATE OATMEAL OATMEAL WATER COCAMIDOPROPYL HYDROXYSULTAINE
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.Triderma MD Eczema Fast Healing TM Body Wash For Sensitive Skin Helps relieve minor skin irritation & itching due to eczema & rashes Colloidal Oatmeal 16 Fl OZ (473 mL) Bottle 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 • on deep puncture wounds • on animals • on bites • on serious burns
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 and 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
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 if • condition worsens • symptoms last for more than 7 days, or clear and occur again in a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • patch test before use • Keep out of eyes. If contact occurs, rinse eyes thoroughly with water.
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 When using this product • patch test before use • Keep out of eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if • condition worsens • symptoms last for more than 7 days, or clear and occur again in a few days Do not use • on deep puncture wounds • on animals • on bites • on serious burns Keep out of reach of children. If swallowed get medical help and 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