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| Product NDC Code | 51672-5318 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bebe bottoms |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SPRAY | ||||||
| RxCUI drug identifier | 1232104 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | TARO PHARMACEUTICALS U.S.A., INC. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc oxide 10%
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 shake well before use 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alkyl-alcohols, alkyl glucoside, calendula officinalis flower extract, caprylyl glycol, caprylhydroxamic acid, chamomilla recutita (matricaria) flower extract, coco-caprylate/caprate, cocoglycerides, glycerin, oleic acid, potassium sorbate, propylene glycol, silica, sodium benzoate, water
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.Bebe Bottoms Zinc Oxide ZINC OXIDE ZINC OXIDE C14-22 ALCOHOLS C12-20 ALKYL GLUCOSIDE CALENDULA OFFICINALIS FLOWER caprylyl glycol caprylhydroxamic acid CHAMOMILE COCOYL CAPRYLOCAPRATE COCO-GLYCERIDES glycerin oleic acid potassium sorbate propylene glycol SILICON DIOXIDE sodium benzoate water
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 - 100 mL Bottle Carton bébé BOTTOMS ™ DIAPER RASH CRÈME SPRAY 10% ZINC OXIDE SKIN PROTECTANT PREVENTS & TREATS FOR DAILY USE NET WT. 3.4 OZ (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
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
Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 PRODUCT OF NETHERLANDS
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 (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-866-923-4914
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 contact a doctor if condition worsens symptoms last more than 7 days or clear up and reoccur within a few days not to be applied over deep or puncture wounds, infection or lacerations
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 room temperature, below 77°F.
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 get into eyes Stop use and contact a doctor if condition worsens symptoms last more than 7 days or clear up and reoccur within a few days not to be applied over deep or puncture wounds, infection or lacerations Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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