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| Product NDC Code | 52358-0001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Baby butz |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| RxCUI drug identifier | 1432509, 1432514 |
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| Application Number | M016 | ||||||||
| Labeler Name | Olen Skin Care Corporation | ||||||||
| 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 Ingredients Zinc Oxide 30%
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 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 diaper my be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients lanolin, 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.Use Helps treat and prevent diaper rash Protects chafed skin due to 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.Baby Butz Zinc Oxide STARCH, CORN LANOLIN PETROLATUM 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 Baby Butz Cream Relieves + Prevents Diaper Rash 100% Natural 30% Zinc Oxide Cream Net Wt 4 oz NDC 52358-0001-2 OLEN SKIN CARE CORPORATION MB, CANADA R2E 0M5 babybutz.com label
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.If condition worsen or does not improve within 7 days, consult a physician.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-494-4313
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 Avoid Contact with eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 15-30 degrees
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
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