Label: SHEFFIELD PAIN RELIEF- benzocaine gel
- NDC Code(s): 11527-062-55
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- do not use tube if it is cut prior to opening
- cut open tip of tube on score mark
- use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
- apply to affected area up to four times daily or as directed by a dentist or physician
- Adults and children 2 years of age and older: Apply to affected area
- Children under 12 years of age should be supervised in the use of this product
- Children under 2 years of age: Consult a doctor
- Other information
- Inactive ingredients
- Principal Display Panel – 0.33oz Carton Label
- Principal Display Panel – 0.33oz Tube Label
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INGREDIENTS AND APPEARANCE
SHEFFIELD PAIN RELIEF
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-062 Route of Administration ORAL 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 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbic Acid (UNII: X045WJ989B) Product Characteristics Color Score Shape Size Flavor SPEARMINT (SPEARMINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-062-55 1 in 1 CARTON 01/30/2006 1 9.35 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 Drug M022 01/30/2006 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(11527-062)