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| Product NDC Code | 10237-775 | ||||
|---|---|---|---|---|---|
| Drug Name | Orajel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, 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.Sodium Fluoride (0.24%) (0.15% w/v fluoride ion)
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 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 denist or physician
| 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 denist or physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural Flavor. All active ingredients are described in the format "ingredient name (source)".
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.Aids in the prevention of dental decay
Purpose
Information about the drug product’s indications for use.Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Orajel Sodium Fluoride SORBITOL SODIUM LAURYL SULFATE FD&C BLUE NO. 1 CARBOXYMETHYLCELLULOSE SODIUM POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM SACCHARIN HYDRATED SILICA WATER SODIUM FLUORIDE FLUORIDE ION 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.JURASSIC WORLD Stage 3 2-10 YEARS Orajel™ kids NATURALLY SOURCED* anti•cavity TOOTHPASTE fluoride NATURAL BERRY BLAST OUR COMMITMENT CERTIFIED RENEWABLE ENERGY Green-e® PROUD SUPPORTER OF Arbor Day Foundation® PLASTIC TUBE how2recycle.info SCAN ME NET WT 4.2 OZ (119 g) Orajel Jurassic Kids Toothpaste.jpg
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 under 6 years of age.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions of comments? Call us at 1-800-952-5080 M-F 9am - 5pm ET or visit our website at orajelkids.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.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