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| Product NDC Code | 74553-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Baby diaper rash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1945076 | ||||
| Application Number | part347 | ||||
| Labeler Name | Xtreme Tools International, 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 17%
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 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 Water (Aqua), Vegetable Oil (Olus Oil in the EU), Butyrospermum parkii (Shea Butter) Fruit, Cocos Nucifera (Coconut) Oil, Glycerin, Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Lavandula Angusfifolia (Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower extract, Shea Butter Ethyl Esters, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydrogenated Vegetable Oil, Heptyl Undecylenate, Polyglyceryl-2 Dipolyhydroxystearate, Cetearyl Alcohol, Polisorbate 60, Myrica Pubescens Fruit wax, Beeswax, Tocopheryl Acetate, Panthenol, Phenoxyethanol, Ethylhexylglycerin, Citric Acid
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 Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.BABY Diaper Rash zinc oxide HEPTYL UNDECYLENATE CETOSTEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE JOJOBA OIL GREEN TEA LEAF ALOE VERA LEAF ALMOND OIL LAVENDER OIL CHAMAEMELUM NOBILE FLOWER SHEA BUTTER CALENDULA OFFICINALIS FLOWER POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE GLYCERIN GRAPE SEED OIL ZINC OXIDE ZINC OXIDE WATER POLYSORBATE 60 MORELLA PUBESCENS FRUIT WAX YELLOW WAX PANTHENOL PHENOXYETHANOL CITRIC ACID MONOHYDRATE COCONUT OIL SHEA BUTTER ETHYL ESTERS ETHYLHEXYLGLYCERIN
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.Principal Display Panel 198 g in Jar; NDC 74553-002-01 cream
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.
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 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM
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 day
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 Store at 20° to 25°C (68° to 77°F) May stain clothing
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