ORAJEL COMPLETE PROTECTION- sodium fluoride paste 
Church & Dwight Co., Inc.

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Orajel Complete Protection Toothpaste

Drug Facts

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

Use

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

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
ORAJEL COMPLETE PROTECTION 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-677
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-677-431 in 1 CARTON01/01/2024
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10237-677-122 in 1 CARTON05/01/2024
2170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02101/01/2024
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-677)

Revised: 12/2023
Document Id: 1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Set id: daebd16f-d278-446d-8b7a-33add5a74fdd
Version: 3
Effective Time: 20231219
 
Church & Dwight Co., Inc.