Gumnumb Topical Anesthetic

Manufacturer
Crosstex International Inc.
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:47:22

Label at a glance#

ProductGumnumb Topical Anesthetic
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200mg

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Use

INDICATIONS & USAGE SECTION

For oral mucosa use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

WARNINGS SECTION

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 the 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use

  • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

Other Information

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

OTC - QUESTIONS SECTION

crosstex@crosstex.com or www.crosstex.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gum Numb Mint Rev 7 OL_newnumber.jpgGum Numb Mint Rev 7 OL_newnumber.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN5
645497GumNumb 20 % Oral GelPSN5
645497benzocaine 0.2 MG/MG Oral Gel [Gum Numb Gel]SBD5
238910benzocaine 0.2 MG/MG Oral GelSCD5
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY5
645497Gum Numb Gel 0.2 MG/MG Oral GelSY5
645497Gumnumb 0.2 MG/MG Oral GelSY5
645497Gumnumb 20 % Oral GelSY5

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24794-221-302025-01-30C16284748780-12cef2736-91e7-d83d-e063-dadaa90ab31f1b3e24cf-ecb6-4ddd-888a-333895eea66d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24794-221-30Gumnumb Topical Anesthetic30 g in 1 JARGEL305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24794-221GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.]5Legacy NDC, 1 package rows20220122_1b3e24cf-ecb6-4ddd-888a-333895eea66d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5P1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1

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
24794-22124794-221-30

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 2 · 98 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQAEROSOL, POWDER / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSPRAY, METERED / NASAL96 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAMUSCULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SOFT TISSUE87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 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
d618d90d-cd4f-4e4d-e053-2a95a90ad09b1b3e24cf-ecb6-4ddd-888a-333895eea66d2022-01-21WarningsExact identifier
spl id: d618d90d-cd4f-4e4d-e053-2a95a90ad09b
spl set id: 1b3e24cf-ecb6-4ddd-888a-333895eea66d