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| Product NDC Code | 57337-055 | ||||
|---|---|---|---|---|---|
| Drug Name | Xtracare with cooling action oatmeal skin relief calmin |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 891710 | ||||
| Application Number | M016 | ||||
| Labeler Name | Rejoice International | ||||
| 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 Purpose Dimethicone 1/3% ......... Skin Protectant
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 as often as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.
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.Use Help prevent and temporarily protects chafed, chapped, or cracked skin.
Purpose
Information about the drug product’s indications for use.XtraCare (with cooling action) Oatmeal Skin Relief Calming Lotion dimethicone skin protectant with natural colloidal oatmeal provides immediate and lasting moisture relief for itchy, extra dry skin 12 fl oz (354 mL)
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone WATER MINERAL OIL PETROLATUM GLYCERIN GLYCERYL MONOSTEARATE PROPYLENE GLYCOL PEG-100 STEARATE POLYACRYLAMIDE (1500 MW) CETYL ALCOHOL OAT DMDM HYDANTOIN STEARYL ALCOHOL C13-14 ISOPARAFFIN LAURETH-7 EDETATE DISODIUM MENTHOL ALOE VERA LEAF METHYLPARABEN PROPYLPARABEN DIMETHICONE DIMETHICONE
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.label image
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 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at room temperature. DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR., NORTHVILLE, MI 48168 USA MADE IN CHINA
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. In case of eye contact, flush with water. 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