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| Product NDC Code | 69435-1501 | ||||
|---|---|---|---|---|---|
| Drug Name | Botao baby diaper rash cream |
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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 | CREAM | ||||
| Application Number | M016 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| 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(in each 30 ml) Zinc Oxide 12% Purpose Sunscreen
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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract, Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides. *Certified Organic
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 seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Botao Baby Diaper Rash Cream ZINC OXIDE HEXASODIUM PHYTATE CAPRYLYL GLYCOL ALGINIC ACID ALOE MICROCRYSTALLINE CELLULOSE WATER GLYCERYL STEARATE SE CETYL ALCOHOL CAPRYLHYDROXAMIC ACID BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES RICINUS COMMUNIS SEED CASTOR OIL GLYCERIN PROPANEDIOL 1-PHOSPHATE CHAMOMILE .BETA.-BISABOLOL XANTHAN GUM CALENDULA OFFICINALIS FLOWER 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.Package Labeling TUBE BOX
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.Drug Facts
Other Information Store in room temparture protect from freezing may stain clothing
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 damaged or broken skin.
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, call a poison control center or get medical help 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 rash or irritation develops and lasts.
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, Keep out of eyes. Rinse with water to remove.
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 damaged or broken skin. When using this product, Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, call a poison control center or get medical help 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