Label: LEADER ORAL PAIN RELIEF ANESTHETIC- benzocaine 20% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-607-05, 37205-607-06 - Packager: Cardinal Health
- 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 24, 2012
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- Active Ingredient
- Purpose
- Uses
- WARNINGS
- INDICATIONS & USAGE
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER ORAL PAIN RELIEF ANESTHETIC
benzocaine 20% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-607 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 SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sorbic Acid (UNII: X045WJ989B) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-607-06 1 in 1 CARTON 1 NDC:37205-607-05 14.2 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part356 08/08/2012 Labeler - Cardinal Health (097537435) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Cardinal Health 097537435 label(37205-607) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 pack(37205-607) Establishment Name Address ID/FEI Business Operations Unipack 009248480 manufacture(37205-607)