Label: ORAL PAIN RELIEF- oral pain reliever gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 67510-0058-4 - Packager: Kareway Product, 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
-
Directions
Directions do not use if tube tip is cut prior to opening; cut open tip of tube on score mark
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
Other informationThis preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted;
do not use continuously - Inactive ingredients
- Active ingredient (in each gram)
- Purpose
- Uses
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ORAL PAIN RELIEF
oral pain reliever gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0058 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:67510-0058-4 1 in 1 CARTON 07/17/2011 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 07/17/2011 Labeler - Kareway Product, Inc. (121840057)
