Orajel™

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g) Nitrate Ion (5 g)

Inactive Ingredients

Water Sodium Bicarbonate Sorbitol Hydrated Silica Glycerin Sodium Lauryl Sulfate Sodium Lauroyl Sarcosinate Poloxamer 407 Xanthan Gum Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-01

Medication Information

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

Section 50570-1

Do not use if irritation occurs and persists.

Section 55105-1

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

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)

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

Section 50570-1 (50570-1)

Do not use if irritation occurs and persists.

Section 55105-1 (55105-1)

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

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 (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? (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 (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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental decay Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact", "42229-5": "Drug Facts", "50565-1": "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.", "50566-9": "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.", "50567-7": "When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.", "50570-1": "Do not use if irritation occurs and persists.", "55105-1": "Active ingredients Purpose Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) Anticavity Potassium Nitrate 5.0% Tooth Desensitizer", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information