TOPICAL ANESTHETIC- benzocaine gel
Topical Anesthetic by
Drug Labeling and Warnings
Topical Anesthetic by is a Prescription medication manufactured, distributed, or labeled by NDC, Inc., Caulk. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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
Topical Anesthetic Gel
20% Benzocaine
CherryREF: 2731001
CHERRY
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-021-30
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PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint
Topical Anesthetic Gel
20% Benzocaine
MintREF: 2731002
MINT
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-023-30
-
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada
Topical Anesthetic Gel
20% Benzocaine
Piña ColadaREF: 2731004
PIÑA COLADA
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-024-30
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PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum
Topical Anesthetic Gel
20% Benzocaine
Bubble GumREF: 2731005
BUBBLE GUM
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-022-30
-
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry
Topical Anesthetic Gel
20% Benzocaine
StrawberryREF: 2731006
STRAWBERRY
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-020-30
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PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry
Topical Anesthetic Gel
20% Benzocaine
RaspberryREF: 2731007
RASPBERRY
Quala®
DENTAL PRODUCTSNET CONTENTS:
1 oz (34g)Rx Only
NDC: 43128-026-30
-
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)
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