Active Ingredients

Manufacturer
Dental Health Products, Inc.
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:52:38

Label at a glance#

ProductHealth-Tec 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200mg (in each g)

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Use

INDICATIONS & USAGE SECTION

For oral mucosal 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.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 of comments?

OTC - QUESTIONS SECTION

800-626-2163

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB.DHPI_Topical Wrap_R2.jpgLB.DHPI_Topical Wrap_R2.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN6
238910benzocaine 0.2 MG/MG Oral GelSCD6
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY6

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
69634-026-302025-01-30C16284748780-12cef2736-755f-d83d-e063-dadaa90ab31fc3fb6705-c647-4fe6-9aca-29735d01d8ea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69634-026-30Health-Tec Topical Anesthetic30 g in 1 JARGEL306

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
69634-02669634-026-30

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 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
56 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRALESIONAL87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAMUSCULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SOFT TISSUE87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRALESIONAL87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRASYNOVIAL3 %w/vExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
56 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSPRAY, METERED / NASAL96 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAMUSCULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii candidate
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSPRAY, METERED / NASAL96 mgExact identifier — unii candidate
56 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
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
ndc (package): 69634-026-30
ndc (product): 69634-026
ndc11 (package): 69634002630
spl id: 4e7fe0fa-1794-3139-e063-6394a90a36cd
spl set id: c3fb6705-c647-4fe6-9aca-29735d01d8ea

Reported adverse events (FAERS/openFDA)#

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