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| Product NDC Code | 10237-795 | ||||
|---|---|---|---|---|---|
| Drug Name | Orajel paw patrol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | part355 | ||||
| Labeler Name | Church & Dwight Co., 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 Sodium fluoride 0.24%
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 Directions twist off cap and remove foil seal do not swallow supervise children as necessary until capable of using without supervision Adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician Children under 6 years Instruct in good brushing and rinsing habits (to minimize swallowing) Children under 2 years ask a dentist of physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1
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 aids in the prevention of dental decay
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Orajel Paw Patrol Sodium fluoride SODIUM FLUORIDE FLUORIDE ION HYDRATED SILICA METHYL SALICYLATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM SODIUM LAURYL SULFATE FD&C BLUE NO. 1 SORBITOL WATER POLYETHYLENE GLYCOL 400 Bubble Berry
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 Bubble Berry Orajel Anticavity Fluoride Toothpaste PAW PATROL nickelodeon NET WT 4.2 OZ (119 g) Kid's Spinbrush + Orajel kids PAWSOME COMBO PACK PAW PATROL nickelodeon COMBO PACK CONTENTS: ONE POWERED TOOTHBRUSH ONE FLUORIDE TOOTHPASTE NET WT. 4.2oz (119g) ONE 3"x4" WATER TATTOO SHEET ONE RINSE CUP CR_DA1097397 OJFC-99889-01
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 Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 us at 800-952-5080 Monday through Friday 9 - 5 ET or visit our website at www.orajel.com
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 Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally 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