Label: ORAJEL INSTANT PAIN RELIEF REGULAR- benzocaine 10% gel
- NDC Code(s): 10237-745-25
- 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 January 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- DO NOT USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions - cut open tip of tube on score mark
- Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. 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 physicaian or healthcare provider
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAJEL INSTANT PAIN RELIEF REGULAR
benzocaine 10% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-745 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-745-25 1 in 1 PACKAGE 12/01/2013 1 2.5 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 12/01/2013 Labeler - Church Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church Dwight Co., Inc. 043690812 manufacture(10237-745)