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NDC 53045-0300-30 Frenna AC 8.75 g/35g Details
Frenna AC 8.75 g/35g
Frenna AC is a DENTAL; ORAL; TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dharma Research, inc.. The primary component is ALUMINUM CHLORIDE.
Product Information
NDC | 53045-0300 |
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Product ID | 53045-300_6b95574e-24cf-4cb9-a23a-284c2981fa33 |
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 | Frenna AC |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aluminum Chloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | DENTAL; ORAL; TOPICAL |
Active Ingredient Strength | 8.75 |
Active Ingredient Units | g/35g |
Substance Name | ALUMINUM CHLORIDE |
Labeler Name | Dharma Research, inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 53045-0300-30 (53045030030)
NDC Package Code | 53045-300-30 |
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Billing NDC | 53045030030 |
Package | 35 g in 1 BOTTLE, PLASTIC (53045-300-30) |
Marketing Start Date | 2013-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d09ae142-6fd5-45e4-a9c4-44428885ccaf Details
SPL UNCLASSIFIED SECTION
INSTRUCTIONS FOR USE
- Soak a cotton tipped applicator with Frenna AC.
- Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulum appear, flush it away with water. This will have no effect on hemostatic action.
- Remove the impregnated cord from sulcus.
- Flush with water and dry with air. If hemostasis is not achieved, repeat application.
- Rinse with water and air dry until bleeding is no longer present.
SPL UNCLASSIFIED SECTION
Frenna AC is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Frenna AC. Stops gingival bleeding fast. If you should anadvertently damage the gingival margin during tooth preparation or while placing a strip, a band, or a cervical matrix, moisten the area with Frenna AC which will control and stop bleeding quickly. Frenna AC contains no epinephrine. The use of casoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided.
A plain gingival retraction cord can be dipped in Frenna AC solution and then placed into the gingival sulcus for its hemostatic action.
INGREDIENTS AND APPEARANCE
FRENNA AC
aluminum chloride solution |
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Labeler - Dharma Research, inc. (078444642) |
Registrant - Dharma Research, inc. (078444642) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Dharma Research, inc. | 078444642 | manufacture(53045-300) |