Label: TOPICAL ANESTHETIC- benzocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 43128-020-30, 43128-021-30, 43128-022-30, 43128-023-30, view more43128-024-30, 43128-026-30 - Packager: NDC, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated September 4, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 1. INDICATIONS AND USAGE
- 2. DOSAGE AND ADMINISTRATION
- 3. DOSAGE FORMS AND STRENGTH
- 4. CONTRAINDICATIONS
-
5. WARNINGS AND PRECAUTIONS
METHEMOGLOBINEMIA WARNING
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:
- •
- pale, gray or blue colored skin (cyanosis)
- •
- headache
- •
- rapid heart rate
- •
- shortness of breath
- •
- dizziness or lightheadedness
- •
- fatigue or lack of energy
- ❖
- Not for use in children under 2 years of age
- ❖
- Keep out of reach of children
- ❖
- For professional dental use only
- ❖
- Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle
- 6. OVERDOSAGE
- 7. DESCRIPTION
- 8. HOW SUPPLIED/STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry
- PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry
-
INGREDIENTS AND APPEARANCE
TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-021 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-021-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-023 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-023-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-024 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-024-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-022 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color PINK Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-022-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-020 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-020-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-026 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Water (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-026-30 34 g in 1 JAR; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963 Labeler - NDC, Inc. (009831413) Establishment Name Address ID/FEI Business Operations Caulk 083235549 MANUFACTURE(43128-021, 43128-023, 43128-024, 43128-022, 43128-020, 43128-026)
