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| Product NDC Code | 79265-8576 | ||||
|---|---|---|---|---|---|
| Drug Name | Babo botanicals sensitive baby fragrance free diaper rash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M016 | ||||
| Labeler Name | Babo Botanicals, 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 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 away 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, Butyrospermum Parkii (Shea) Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Olea Europaea (Olive) Oil Unsaponifiables, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Glyceryl Oleate. *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.Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Zinc Oxide CELLULOSE, MICROCRYSTALLINE ZINC OXIDE ZINC OXIDE ALOE VERA LEAF OLIVE OIL CASTOR OIL GLYCERIN CAPRYLHYDROXAMIC ACID PROPANEDIOL GLYCERYL ROSINATE BENTONITE NASTURTIUM OFFICINALE FLOWERING TOP CALENDULA OFFICINALIS FLOWER CETOSTEARYL ALCOHOL CHAMOMILE SHEA BUTTER SUNFLOWER OIL FILIPENDULA ULMARIA FLOWER CAPRYLYL GLYCOL OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED WATER GLYCERYL OLEATE COCO GLUCOSIDE
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 Dist by Babo Botanicals, Inc. 60 East 56th Street New York, NY 10022
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces.
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 1-800-422-2987 Mon-Fri 9:00AM - 5:00PM EST
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 occurs 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 symptoms last more than 7 days or clear up and occurs 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