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NDC 71101-0201-01 TheraCare Maximum Strength Oral Pain Relief 10; 200 mg/g; mg/g Details
TheraCare Maximum Strength Oral Pain Relief 10; 200 mg/g; mg/g
TheraCare Maximum Strength Oral Pain Relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. The primary component is BENZALKONIUM CHLORIDE; BENZOCAINE.
Product Information
| NDC | 71101-0201 |
|---|---|
| Product ID | 71101-201_eb7928eb-82fe-46c4-e053-2a95a90aa268 |
| 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 | TheraCare Maximum Strength Oral Pain Relief |
| Proprietary Name Suffix | Severe |
| Non-Proprietary Name | Benzocaine 20%, Benzalkonium Chloride 1% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 10; 200 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | BENZALKONIUM CHLORIDE; BENZOCAINE |
| Labeler Name | Veridian Healthcare |
| 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 71101-0201-01 (71101020101)
| NDC Package Code | 71101-201-01 |
|---|---|
| Billing NDC | 71101020101 |
| Package | 1 TUBE in 1 CARTON (71101-201-01) / 9.35 g in 1 TUBE |
| Marketing Start Date | 2022-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d8270f1c-b44e-ae00-e053-2a95a90aa409 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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physician or healthcare provider
Other information
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- do not use if tube seal under cap is broken
- store at 20-25C (68-77F)
Inactive ingredients
INGREDIENTS AND APPEARANCE
| THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF
SEVERE
benzocaine 20%, benzalkonium chloride 1% gel |
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| Labeler - Veridian Healthcare (830437997) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ANICARE PHARMACEUTICALS PRIVATE LIMITED | 916837425 | manufacture(71101-201) | |
Revised: 10/2022
Document Id: eb7928eb-82fe-46c4-e053-2a95a90aa268
Set id: d8270f1c-b44e-ae00-e053-2a95a90aa409
Version: 2
Effective Time: 20221020