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Product NDC Code | 10237-677 | ||||||
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Drug Name | Orajel complete protection |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | PASTE | ||||||
Application Number | M021 | ||||||
Labeler Name | Church & Dwight Co., Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) Anticavity Potassium Nitrate 5.0% Tooth Desensitizer
Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) | Anticavity |
Potassium Nitrate 5.0% | Tooth Desensitizer |
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 Do not swallow Supervise children as necessary until capable of using without supervision Rinse away toothpaste residue thoroughly after brushing Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, flavor, sodium lauryl sulfate, sodium saccharin, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide
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 Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) Anticavity Potassium Nitrate 5.0% Tooth Desensitizer
Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) | Anticavity |
Potassium Nitrate 5.0% | Tooth Desensitizer |
Spl product data elements
Usually a list of ingredients in a drug product.Orajel Complete Protection Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION WATER SODIUM BICARBONATE SORBITOL HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE POLOXAMER 407 XANTHAN GUM TITANIUM DIOXIDE
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 - 121.9 g Tube Carton NEW #1 ORAL PAIN RELIEF BRAND Orajel ™ Anticavity Toothpaste For Sensitive Teeth DEEP CLEAN MINT COMPLETE PROTECTION DEEP CLEANING SENSITIVE TOOTHPASTE Gently whitens and strengthens enamel Helps remove plaque bacteria NET WT 4.3 OZ (121.9 g) PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if irritation occurs and persists.
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. 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 1-800-786-5135 Mon.– Fri. 9am–5pm ET or visit www.orajel.com
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 dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
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 use longer than 4 weeks unless recommended by a dentist or physician.
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 Do not use if irritation occurs and persists. When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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