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| Product NDC Code | 67777-408 | ||||
|---|---|---|---|---|---|
| Drug Name | Dynashield with dimethicone |
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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 | 2644139 | ||||
| Application Number | M016 | ||||
| Labeler Name | Dynarex Corporation | ||||
| 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 Ingredients Zinc Oxide 2% Dimethicone 1.8%
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 • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. • For other uses: Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Tartrazine, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Soft Paraffin
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 • Use as a general skin protectant • Helps treat chafed skin associated with diaper rash • Dries the oozing and weeping of poison ivy, oak, and sumac
Purpose
Information about the drug product’s indications for use.Purpose Diaper rash Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Dynashield with Dimethicone zinc oxide DIMETHICONE DIMETHICONE WHITE PETROLATUM METHYLPARABEN VITAMIN A ACETATE LAVENDER OIL LANOLIN CETETH-20 MINERAL OIL PROPYLPARABEN GLYCERIN CETYL ALCOHOL CETOSTEARYL ALCOHOL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALOE VERA LEAF FD&C YELLOW NO. 5 TROLAMINE WATER ZINC OXIDE ZINC OXIDE
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 DynaShield with Dimehticone 1199 IN MASTER
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information • Store at room temperature between 15 0 - 30 0 C (59 0 - 86 0 F) • Avoid excessive heat • Tamper evident. Do not use if seal is damaged.
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 (1-800-222-1222) 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 and Comments? 1-888-396-2739, Monday - Friday 9AM-5PM EST
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
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: • Avoid contact with eyes • Do not use over large areas of the body • So not use if you are allergic to any of the ingredients
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 • Do not use over large areas of the body • So not use if you are allergic to any of the ingredients 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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