FDA Label for Orajel Sensitivity Relief
View Indications, Usage & Precautions
Orajel Sensitivity Relief Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) | Anticavity |
| Potassium Nitrate 5.0% | Tooth Desensitizer |
Use
- Aids in the prevention of dental decay
- Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Otc - Do Not Use
Do not use if irritation occurs and persists.
Otc - When Using
When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.
Otc - Stop Use
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.
Otc - 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.
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 Ingredients
Sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium saccharin
Questions Or Comments?
Call 1-800-786-5135 Mon.–Fri. 9am–5pm ET or visit www.orajel.com
Principal Display Panel - 121.9 G Tube Carton
NEW
#1 ORAL PAIN RELIEF BRAND
Orajel™
Anticavity Toothpaste
For Sensitive Teeth
SOOTHING MINT
SENSITIVITY RELIEF
24/7 SENSITIVITY RELIEF TOOTHPASTE*
Maxiumum sensitivity relief without a prescription
Sensitivity protection from hot and cold
NET WT 4.3 OZ (121.9 g)
* Please review the disclaimer below.