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Product NDC Code | 79747-003 | ||||
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Drug Name | Boogie bottoms no-rub diaper rash |
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Type | Brand | ||||
Pharm Class | Skin Barrier Activity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 968817 | ||||
Application Number | M016 | ||||
Labeler Name | ELEEO BRANDS LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Zinc Oxide 25% Skin Protectant Dimethicone 20% Skin Protectant
Zinc Oxide 25% | Skin Protectant |
Dimethicone 20% | Skin Protectant |
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 diaper area and allow to dry. Shake bottle well before use. Unlock to spray. Re-lock when not in use. Spray 4-6 inches from skin. No rub-in is required. Apply 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 Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum
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.Active ingredients Purpose Zinc Oxide 25% Skin Protectant Dimethicone 20% Skin Protectant
Zinc Oxide 25% | Skin Protectant |
Dimethicone 20% | Skin Protectant |
Spl product data elements
Usually a list of ingredients in a drug product.Boogie Bottoms No-Rub Diaper Rash Dimethicone and Zinc Oxide CYCLOMETHICONE HEXAMETHYLDISILOXANE LANOLIN MINERAL OIL MICROCRYSTALLINE WAX PETROLATUM VITAMIN A PALMITATE CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- CORN OIL DIMETHICONE DIMETHICONE 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.PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label NEW! NDC 79747-003-01 Boogie BOTTOMS™ No-Rub Diaper Rash Spray Skin Protectant SHAKE WELL Treats & Prevents diaper rash Spray-on application Fast & Easy to use 25% Zinc Oxide Free from: fragrances • dyes • parabens NET 1.7 FL OZ (49ML) 12
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 Nehemiah Manufacturing Co, 1907 South St, Cincinnati, OH U.S.A. 45204
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. Lock when not in use. If swallowed, get medical help or contact a poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1.877.469.8877 - MADE IN USA
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 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. If contact occurs, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 59° F - 87° 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. If contact occurs, rinse eyes thoroughly with water. Stop use and ask 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. Lock when not in use. If swallowed, get medical help or contact a poison control center immediately.
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