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Xtracare skin relief oatmeal daily moisturizing - Medication Information

Product NDC Code 57337-037
Drug Name

Xtracare skin relief oatmeal daily moisturizing

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 5 mg/354mg
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 891710
Application Number M016
Labeler Name Rejoice International
Packages
Package NDC Code Description
57337-037-01 354 mg in 1 bottle (57337-037-01)
57337-037-02 227 mg in 1 bottle (57337-037-02)
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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, 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 protets chafed, chapped, or cracked skin.

Purpose

Information about the drug product’s indications for use.
XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion dimethicone skin protectant with soothing oat essence To Protect & Relieve Dry Skin 12 fl oz (354 mL)

Spl product data elements

Usually a list of ingredients in a drug product.
XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone WATER MINERAL OIL ISOPROPYL MYRISTATE 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 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 label 2 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 right away.

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