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Drug Facts
Orajel Complete Protection Paste
FDA Label NDC 10237-677
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel Complete Protection (NDC 10237-677). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, use, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, flavor, sodium lauryl sulfate, sodium saccharin, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide
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
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)
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