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Product NDC Code | 64768-2928 | ||||
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Drug Name | Mustela diaper rash sprayable |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 2595464 | ||||
Application Number | M016 | ||||
Labeler Name | Expanscience Laboratories d/b/a Mustela | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide (Non-Nano) 14.9%
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. Spray 4-6 inches from skin. Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. No need to rub in.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients WATER (AQUA), OLEA EUROPAEA (OLIVE) FRUIT OIL, PROPANEDIOL, RICINUS COMMUNIS (CASTOR) SEED OIL, BENTONITE, GLYCERYL ROSINATE, CETEARYL ALCOHOL, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES, GLYCERIN, GLYCERYL OLEATE, COCO-GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, CELLULOSE GUM, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL *Certified Organic Ingredients
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 associated with diaper rash 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.Mustela Diaper Rash Sprayable ZINC OXIDE BENTONITE CHAMOMILE COCO GLUCOSIDE CETOSTEARYL ALCOHOL OLIVE OIL PROPANEDIOL CASTOR OIL GLYCERYL ROSINATE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL GLYCERYL OLEATE GLYCERIN SUNFLOWER OIL CALENDULA OFFICINALIS FLOWER AVOCADO ALOE VERA LEAF OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SHEA BUTTER WATER 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.Product Packaging 1
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
Company information MADE IN THE USA from globally sourced materials for Expanscience Laboratories Inc., Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022 www.MustelaUSA.com For sale only through select retailers.
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 or 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
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 ask a doctor if condition worsens or 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