Label: BUDPAK ORAL MAXIMUM STRENGTH- benzocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 27293-019-01, 27293-019-14 - Packager: Budpak 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 June 8, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
adults and children 2 years of age and older:
- break seal on tube
- apply to the affected area up to 4 times daily or as directed by a dentist or a doctor
- children under 12 years of age should be supervised in the use of the product
- children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BUDPAK ORAL MAXIMUM STRENGTH
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27293-019-01 1 in 1 BOX 1 NDC:27293-019-14 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/10/2013 Labeler - Budpak Inc. (183224849) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(27293-019)