Label: MARK 3- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61509-102-32 - Packager: Cargus International, 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 March 23, 2021
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
MARK 3
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61509-102 Route of Administration ORAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6.4 g in 32 g Inactive Ingredients Ingredient Name Strength FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61509-102-32 32 g in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/28/2014 Labeler - Cargus International, Inc. (096191093) Establishment Name Address ID/FEI Business Operations Dharma Research, Inc. 078444642 manufacture(61509-102)