ORAJEL SENSITIVITY RELIEF- sodium fluoride and potassium nitrate paste, dentifrice

Orajel Sensitivity Relief by

Drug Labeling and Warnings

Orajel Sensitivity Relief by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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.

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)

INGREDIENTS AND APPEARANCE

ORAJEL SENSITIVITY RELIEF 
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-678
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-678-43	121.9 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2024
2	NDC: 10237-678-12	2 in 1 CARTON	06/01/2024
2		170 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	01/31/2024

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	MANUFACTURE(10237-678)