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NDC 70721-0001-30 Defend 200 mg/g Details
Defend 200 mg/g
Defend is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Mydent International. The primary component is BENZOCAINE.
Product Information
NDC | 70721-0001 |
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Product ID | 70721-001_d65595c8-b75b-92a7-e053-2995a90a6a4b |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Defend |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Benzocaine |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | DENTAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/g |
Substance Name | BENZOCAINE |
Labeler Name | Mydent International |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 70721-0001-30 (70721000130)
NDC Package Code | 70721-001-30 |
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Billing NDC | 70721000130 |
Package | 30 g in 1 JAR (70721-001-30) |
Marketing Start Date | 2018-07-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ba011795-6822-4fff-b9c8-5c91cf9972a7 Details
Use
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child 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
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
- for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
- for teething
- in children under 2 years of age
When using this product Avoid contact with eyes. If contact occurs, flush with water.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.
Directions
Inactive ingredients
INGREDIENTS AND APPEARANCE
DEFEND
benzocaine gel |
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Labeler - Mydent International (176970747) |