Orajel Sensitivity Relief

SODIUM FLUORIDE AND POTASSIUM NITRATE ORAL HUMAN OTC DRUG

Orajel Sensitivity Relief is an FDA drug label for the active ingredient SODIUM FLUORIDE AND POTASSIUM NITRATE manufactured by Church & Dwight Co., Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231219.

Generic name
SODIUM FLUORIDE AND POTASSIUM NITRATE
Manufacturer
Church & Dwight Co., Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
10237-678
Application
M021
Label effective
20231219

Active ingredients

Active ingredients Purpose Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) Anticavity Potassium Nitrate 5.0% Tooth Desensitizer

Indications & Usage

Use Aids in the prevention of dental decay Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Dosage & Administration

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.

Contraindications

Not available.

Warnings

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.

Adverse Reactions

Not available.

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