Frenna AC

Manufacturer
Dharma Research, inc.
Effective date
2020-11-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:33:53

Label at a glance#

ProductFrenna AC
Active ingredientALUMINUM CHLORIDE
Label structure6 sections

Storage and handling

Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION

  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Distilled Water, Potassium Chloride, Propylene Glycol.

WARNINGS AND PRECAUTIONS SECTION

  • Discontinue use if irritation appears.
  • For topical application only.
  • Avoid eye contact.
  • Do not use in patients with a known history of hyper sensetivity to Aluminum Chloride.
  • For professional use only.
  • Federal law restricts this product to sale or use on the order of a dentist.

INSTRUCTIONS FOR USE SECTION

  • 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.

INDICATIONS & USAGE 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMGIMG

IMG2IMG2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244613aluminum chloride 25 % Topical SolutionPSN2
244613aluminum chloride 250 MG/ML Topical SolutionSCD2
244613aluminum chloride 25 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53045-300-302020-11-06C16284748780-19d75b9d0-9472-f424-e053-dadaa90a57ced09ae142-6fd5-45e4-a9c4-44428885ccaf
53045-300-302020-01-31C16284748780-19d75b9d0-9472-f424-e053-dadaa90a57ced09ae142-6fd5-45e4-a9c4-44428885ccaf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-300-30Frenna AC35 g in 1 BOTTLE, PLASTICSOLUTION352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-300FRENNA AC (ALUMINUM CHLORIDE) SOLUTION [DHARMA RESEARCH, INC.]2Current NDC, Legacy NDC, 1 package rows20201107_d09ae142-6fd5-45e4-a9c4-44428885ccaf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM CHLORIDEACTIVE INGREDIENT3CYT62D3GA1
ALUMINUM CATIONACTIVE MOIETY3XHB1D032B1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I101
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53045-30053045-300-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 38 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SUSPENSION / ORALNAExact identifier — unii+route
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10TABLET / ORAL231 mgExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE / ORAL62 mgExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOAP / TOPICALNAExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SUSPENSION / ORALNAExact identifier — unii+route
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOAP / TOPICALNAExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE / ORAL62 mgExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+dosage form
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10TABLET / ORAL231 mgExact identifier — unii+route
28 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frenna ACALUMINUM CHLORIDEDharma Research, inc.d09ae142-6fd5-45e4-a9c4-44428885ccaf2020-11-06WarningsExact identifier
ndc (package): 53045-300-30
ndc (product): 53045-300
ndc11 (package): 53045030030
spl id: 6b95574e-24cf-4cb9-a23a-284c2981fa33
spl set id: d09ae142-6fd5-45e4-a9c4-44428885ccaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.