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Product NDC Code | 83092-104 | ||||
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Drug Name | Eczema relief soothing wash 2% colloidal oatmeal |
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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 | GEL | ||||
RxCUI drug identifier | 2172890 | ||||
Application Number | M016 | ||||
Labeler Name | Three Dog Beauty LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT COLLOIDAL OATMEAL 2%
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 AS NEEDED OR AS DIRECTED BY A DOCTOR. CHILDREN UNDER 2 YEARS: CONSULT A DOCTOR
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, SODIUM COCOYL ISETHIONATE, COCAMIDOPROPYL HYDROXYSULTAINE, SODIUM LAURYL SARCOSINATE, GLYCERIN, DECYL GLUCOSIDE, GLYCOL STEARATE, GLYCERYL CAPRYLATE, ARGANIA SPINOSA KERNEL OIL, CAPRYLHYDROXAMIC ACID, ALOE BARBADENSIS LEAF EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HIBISCUS SABDARIFFA FLOWER EXTRACT, PANTHENOL, BROMELAIN, NIACINAMIDE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, PHOSPHOLIPIDS, SPHINGOLIPIDS, TOCOPHEROL
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.
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 RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL COLLOIDAL OATMEAL GLYCERYL CAPRYLATE ARGAN OIL CAPRYLHYDROXAMIC ACID PANTHENOL BROMELAINS SOY SPHINGOLIPIDS EGG PHOSPHOLIPIDS NIACINAMIDE GLYCOL STEARATE ALOE VERA LEAF SUNFLOWER OIL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) TOCOPHEROL DECYL GLUCOSIDE JOJOBA OIL HIBISCUS SABDARIFFA FLOWER GLYCERIN WATER SODIUM COCOYL ISETHIONATE COCAMIDOPROPYL HYDROXYSULTAINE SODIUM LAURYL SARCOSINATE 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.01b LBL_Eczema Wash_10oz
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 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? WWW.NAKERYBEAUTY.COM
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. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. STOP USE AND ASK A DOCTOR IF CONDITION WORSENS SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.
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