Label: ORAL ANALGESIC MAXIMUM STRENGTH- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51852-101-01 - Packager: LIFElabs, a Division of Atico International USA, INC.
- Category: HUMAN OTC DRUG LABEL
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 August 17, 2010
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- Official Label (Printer Friendly)
- Oral Analgesic (Maximum Strength)
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- remove cap and cut tip of tube on score mark
- adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. use up to 4 times daily or as directed by a doctor or dentist.
- children under 12 year of age: should be supervised in the use of this product
- children under 2 years of age: ask a doctor/dentist
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAL ANALGESIC MAXIMUM STRENGTH
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51852-101 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 Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Peppermint (UNII: V95R5KMY2B) Polyethylene Glycol 400 (UNII: B697894SGQ) Polyethylene Glycol 4000 (UNII: 4R4HFI6D95) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51852-101-01 1 in 1 CARTON 1 11.9 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/01/2010 Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)