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| Product NDC Code | 11086-021 | ||||||||||||
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| Drug Name | Triple medicated for diaper rash |
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| Type | Brand | ||||||||||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | PASTE | ||||||||||||
| RxCUI drug identifier | 637168, 729935 |
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| Application Number | M016 | ||||||||||||
| Labeler Name | Summers Laboratories Inc | ||||||||||||
| 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 ZINC OXIDE 12.8%
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 Change wet and soiled diapers promptly Cleanse the diaper area and allow skin to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.
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 TREAT AND PREVENT DIAPER RASH PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS
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.TRIPLE MEDICATED FOR DIAPER RASH ZINC OXIDE PETROLATUM STARCH, CORN LANOLIN STEARYL ALCOHOL YELLOW WAX .ALPHA.-BISABOLOL, (+)- CHOLESTEROL WATER GLYCERIN OAT POLYSORBATE 80 ZINC OXIDE ZINC CATION
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.Triple Paste 2 oz_Unit Carton Triple Paste 8oz label Triple Paste 16 oz label
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 CONTCT A POISON CONTROL CENTER RIGHT AWAY.
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 and ask a doctor if condition worsens or does not improve within 7 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 DO NOT GET INTO EYES
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
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