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| Product NDC Code | 71630-549 | ||||
|---|---|---|---|---|---|
| Drug Name | Baby diaper rash cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1125471 | ||||
| Application Number | M020 | ||||
| Labeler Name | doTERRA International, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 25% Zinc Oxide
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.Active ingredient Purpose Zinc Oxide 25%...........................Skin Protectant Directions • Change wet or 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 any time exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis (Jojoba) Seed Oil, Beeswax (Cera Alba), Butyrospermum parkii (Shea) Butter, Carthamus tinctorius (Safflower) Oleosomes, Water (Aqua), Caprylyl Glycol, Lavandula angustifolia (Lavender) Oil, Daucus carota sativa (Carrot) Seed Oil, Melaleuca alternifolia (Tea Tree) Leaf Oil DFP
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.Skin protectant Drug Facts
Spl product data elements
Usually a list of ingredients in a drug product.Baby Diaper Rash Cream Zinc oxide WATER MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL CARROT SEED OIL YELLOW WAX CAPRYLYL GLYCOL LAVENDER OIL TEA TREE OIL CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES ZINC OXIDE ZINC OXIDE SHEA BUTTER
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 and Package Label doTERRA® baby Diaper Rash Cream Helps Treat, Soothe, and Prevent Diaper Rash Net wt. 2.1 oz/60 g PDP
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 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Store between 20º to 25ºC (68º to 77ºF) • Do not use if quality seal is broken
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-411-8151
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 DF Diaper Cream
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.For external use only. Drug Facts
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