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NDC 50804-0191-10 Goodsense Oral Pain Relief 20 g/100g Details
Goodsense Oral Pain Relief 20 g/100g
Goodsense Oral Pain Relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Geiss, Destin and Dunn, Inc.. The primary component is BENZOCAINE.
Product Information
| NDC | 50804-0191 |
|---|---|
| Product ID | 50804-191_dfdced39-6938-4f2d-e053-2a95a90a6f2e |
| Associated GPIs | 88350010004040 |
| GCN Sequence Number | 003481 |
| GCN Sequence Number Description | benzocaine GEL (GRAM) 20 % MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 12200 |
| HICL Sequence Number | 001516 |
| HICL Sequence Number Description | BENZOCAINE |
| Brand/Generic | Generic |
| Proprietary Name | Goodsense Oral Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | g/100g |
| Substance Name | BENZOCAINE |
| Labeler Name | Geiss, Destin and Dunn, Inc. |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 50804-0191-10 (50804019110)
| NDC Package Code | 50804-191-10 |
|---|---|
| Billing NDC | 50804019110 |
| Package | 1 TUBE in 1 CARTON (50804-191-10) / 14 g in 1 TUBE |
| Marketing Start Date | 2018-12-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL eb461b70-d10f-4e11-8374-e43713f3504d Details
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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 blood. This can occur even if you have use 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 this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
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Directions
| Adults and children 2 years of age and older |
Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. |
| Children under 12 years of age. | Should be supervised in the use of this product. |
| Children under 2 years of age. | Do not use. |
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INGREDIENTS AND APPEARANCE
| GOODSENSE ORAL PAIN RELIEF
benzocaine gel |
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| Labeler - Geiss, Destin and Dunn, Inc. (076059836) |