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| Product NDC Code | 66977-022 | ||||
|---|---|---|---|---|---|
| Drug Name | Norml shield |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 359450, 1364539 |
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| Application Number | M016 | ||||
| Labeler Name | MPM Medical LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone 4.5%
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 Adults and children 2 years of age and older: Cleanse affected area. Allow to dry. Apply MPM NormlShield® liberally. Apply as needed. Children under 2 years of age: Consult a physician prior to use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe barbadensis leaf extract, Cetearyl alcohol and polysorbate 60, Cetyl alcohol, Deionized water, DMDM hydantoin, Glycol stearate, Imidiazolidinyl urea, Isopropyl palmitate, Methylparaben, Mineral oil, PEG-40 hydrogenated castor oil, Propylene glycol, Propylparaben, Stearic acid, Stearyl Alcohol, Tocopheryl acetate, Triethanolamine
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 Helps prevent and temporarily protects chafed, chapped or cracked skin
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.Norml Shield dimethicone CETOSTEARYL ALCOHOL ALOE VERA LEAF POLYSORBATE 60 CETYL ALCOHOL WATER DMDM HYDANTOIN GLYCOL STEARATE IMIDUREA ISOPROPYL PALMITATE METHYLPARABEN MINERAL OIL PEG-40 CASTOR OIL PROPYLENE GLYCOL PROPYLPARABEN STEARIC ACID STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE 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.Package Label NormlShield R0720 Directions Adults and children 2 years of age and older: Cleanse affected area. Allow to dry. Apply MPM NormlShield® liberally. Apply as needed. Children under 2 years of age: Consult a physician prior to use.
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 or puncture wounds animal bites 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. When using this product do not get into 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 Do not use on deep or puncture wounds animal bites serious burns
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 more than 7 days or clear up and occur again within a few days Do not use on deep or puncture wounds animal bites serious burns
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 do not get into 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 Do not use on deep or puncture wounds animal bites serious burns
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. If swollowed, get medical help or contact Poison Control Center right away. Keep out of reach of children. When using this product do not get into 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 Do not use on deep or puncture wounds animal bites serious burns
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