Label: ORAL PAIN RELIEF- oral pain reliever gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53943-996-42 - Packager: Discount Drug Mart, 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 December 27, 2017
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
- Uses
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Warnings
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
Flammable: keep away from fire or flame. Avoid smoking during application and until this product has dried.
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Directions
Directions cut open tip of tube
Adults and children 2 years of age and over Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor Children under 12 years of age
Should be supervised in the use of this product Children under 2 years of age Ask a dentist or doctor - Inactive ingredients
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAL PAIN RELIEF
oral pain reliever gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-996 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-996-42 1 in 1 CARTON 11/09/2015 1 11.9 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 11/09/2015 Labeler - Discount Drug Mart, Inc. (047741335)