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Product NDC Code | 73088-301 | ||||||||||
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Drug Name | Sweet cheeks diaper |
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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 | ||||||||||
Application Number | M016 | ||||||||||
Labeler Name | Tubby Todd | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 14%
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.Drug Facts
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Beeswax*, Butyrospermum Parkii (Shea) Butter*, Caprylic/Capric Triglyceride*, Helianthus Annuus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Tocopherol *Certified Organic Ingredient(s)
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 chaftes skin due to diaper rash and helps seal out 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.Sweet Cheeks Diaper Zinc Oxide RICINUS COMMUNIS (CASTOR) SEED OIL BEESWAX SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL TOCOPHEROL ZINC OXIDE ZINC CATION HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL CAPRYLIC/CAPRIC TRIGLYCERIDE BUTYROSPERMUM PARKII (SHEA) BUTTER
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.Tubby Todd Sweet Cheeks Diaper Paste 01b LBL_TT_Sweet Cheeks_7.9oz.
Instructions for use
Information about safe handling and use of the drug product.Directions Change wet or 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 any time exposure to wet diapers may be prolonged
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, seek medical advice 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 between 68° to 77°F Do not use if quality seal is broken
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call (619) 894-6540
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 do not use near eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens. Symptoms may last more than 7 days Keep out of reach of children. If swallowed, seek medical advice or contact a Poison Control Center immediately.
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