Brace Relief

Manufacturer
InfaLab,Inc | PhytogenX,Inc.
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:34:04

Label at a glance#

ProductBrace Relief
Active ingredientBenzocaine
Label structure8 sections

Dosage and administration

Apply to irritated areas as needed See package insert for instructions, warnings & cautions.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 9%

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

PEG 8, PEG 75, Glycerine, Tincture of Myrrh, Menthol, Phenol, Clove Oil, Methyl Salicylate, Peppermint Oil, Methyl Paraben, Propyl Paraben.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply to irritated areas as needed See package insert for instructions, warnings & cautions.

CAUTION:

WARNINGS SECTION

For temporary relief only.

Dist.by Infa-Lab Inc., Rockaway, NJ 07866
1996 INFA-LAB INC., Rockaway, NJ

OTC - PURPOSE SECTION

 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 

INDICATIONS & USAGE SECTION

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

INfALAB®
MAGIC TOUCH

BraceRelief™
ANESTHETIC GEL IN AN ANTISEPTIC BASE
Relieves mouth pain
Net Wt. 3 g.
NDC#603061155

Principal Display Panel – Tube Label
Principal Display Panel – Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1547591benzocaine 9 % Oral GelPSN12
1547593Brace Relief 9 % Oral GelPSN12
1547593benzocaine 0.09 MG/MG Oral Gel [Brace Relief]SBD12
1547591benzocaine 0.09 MG/MG Oral GelSCD12
1547591benzocaine 9 % Oral GelSY12
1547593Brace Relief 0.09 MG/MG Oral GelSY12
1547593Brace Relief 9 % Oral GelSY12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60306-115-05Brace Relief0.3 mL in 1 TUBEGEL0.312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
Clove OilINACTIVE INGREDIENT578389D6D01
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
MentholINACTIVE INGREDIENTL7T10EIP3A1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022Y1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
MyrrhINACTIVE INGREDIENTJC71GJ1F3L1
Peppermint OilINACTIVE INGREDIENTAV092KU4JH1
PhenolINACTIVE INGREDIENT339NCG44TV1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQ1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60306-11560306-115-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 5 · 274 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION, SOLUTION / INTRAMUSCULAR75 mgExact identifier — unii candidate
38 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii+route
20 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
36 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii+route
22 equally ranked IID candidates
Methyl SalicylateMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
46 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+dosage form
42 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route
38 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
36 equally ranked IID candidates
PhenolPHENOL339NCG44TVDOUCHE / VAGINAL0.14 %w/wExact identifier — unii candidate
38 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION / INTRADERMAL0.25 %w/vExact identifier — unii candidate
38 equally ranked IID candidates
Clove OilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii+route
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
46 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii+route
36 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route
46 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION / SUBCUTANEOUS48 mgExact identifier — unii candidate
38 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
38 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route
42 equally ranked IID candidates
PhenolPHENOL339NCG44TVSOLUTION / INTRAVENOUS23 mgExact identifier — unii candidate
38 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii+route
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
46 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii+route
20 equally ranked IID candidates
PhenolPHENOL339NCG44TVLIQUID / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
38 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
46 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii+route
42 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii+route
20 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii+route
20 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii+route
42 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION / INTRALESIONAL0.5 %w/vExact identifier — unii candidate
38 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
36 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii+route
20 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION / INTRAMUSCULAR48 mgExact identifier — unii candidate
38 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
46 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
36 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route
46 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route
46 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii+route
42 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route
38 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+dosage form
42 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
42 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
36 equally ranked IID candidates
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route
46 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii+route
46 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii+route
46 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
46 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route
46 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
38 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
36 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
46 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
46 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route
38 equally ranked IID candidates
PhenolPHENOL339NCG44TVINJECTION, SOLUTION / INTRAVENOUS75 mgExact identifier — unii candidate
38 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…

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
Brace ReliefBENZOCAINEInfaLab,Incd7e57d67-4234-44a9-bbd3-72e99cd5bdb32026-01-16WarningsExact identifier
ndc (package): 60306-115-05
ndc (product): 60306-115
ndc11 (package): 60306011505
spl id: c4d6e935-9aaa-430e-ae72-51d4c84fcbf4
spl set id: d7e57d67-4234-44a9-bbd3-72e99cd5bdb3

Reported adverse events (FAERS/openFDA)#

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