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Product NDC Code | 62654-145 | ||||||
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Drug Name | Boa vida calvida |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 417425 | ||||||
Application Number | part347 | ||||||
Labeler Name | Central Solutions Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 20% (w/w)
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 product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. For Skin Protection: Apply liberally as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)
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 minor skin irritation 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.BOA VIDA Calvida ZINC OXIDE WATER POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE MINERAL OIL ISOPROPYL PALMITATE ETHYLHEXYL PALMITATE THEOBROMA GRANDIFLORUM SEED GLYCERIN DIMETHICONE SODIUM CHLORIDE DIAZOLIDINYL UREA MENTHOL HYDROGENATED CASTOR OIL YELLOW WAX TOCOPHEROL METHYLPARABEN CORN OIL VITAMIN A PALMITATE CHOLECALCIFEROL 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.BOA VIDA Calvida protectant shield helps treat minor skin irritation Formulated with Cupuacu Butter 5 fl oz. (148 mL) container label
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 on animal bites on 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 If swallowed, get medical help or contact 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 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 do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect from freezing. Avoid excessive heat
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 Do not use on deep or puncture wounds on animal bites on serious burns 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 Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center 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