Label: ORAJEL DENTURE PAIN RELIEF- benzocaine, benzalkonium chloride, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10237-765-25 - Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
cut open tube on score mark
Adults and children 2 years of age and over:
Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Use up to 4 times daily or as directed by a physician or healthcare provider.
Children under 12 years of age:
Should be supervised in the use of this product
Children under 2 years of age:
Ask a physician or healthcare provider
Other Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
#1
Oral Pain
Reliever Brand
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New Formula!
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Active Ingredients*
Orajel
Instant Pain Relief
For Denture Pain
Soothes Gum Pain & Irritation
Triple Medicated
10% Benzocaine to Relieve Pain from Dentures
Astringent to Relieve Gum Irriation NEW
Menthol to Soothe Gums Irritated by Dentures
Refreshing Mint
Long-Lasting Gel
Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)
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INGREDIENTS AND APPEARANCE
ORAJEL DENTURE PAIN RELIEF
benzocaine, benzalkonium chloride, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-765 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 26 mg in 1 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PECTIN (UNII: 89NA02M4RX) PETROLATUM (UNII: 4T6H12BN9U) GELATIN (UNII: 2G86QN327L) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-765-25 1 in 1 CARTON 07/01/2016 10/18/2019 1 1 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 not final part356 07/01/2016 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 253933600 manufacture(10237-765)