FDA.reportPublic FDA data

Pain Relief

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:45

Label at a glance#

ProductPain Relief
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

temporarily relieves pain caused by toothache dental work minor irritation or injury of the mouth and gums canker sores gum sores cheek bites denture irritation

Dosage and administration

adults and children 2 years of age and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. children under 2 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% (w/w)

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain caused by

  • toothache
  • dental work
  • minor irritation or injury of the mouth and gums
  • canker sores
  • gum sores
  • cheek bites
  • denture irritation

Warnings

WARNINGS SECTION

For oral use only.Avoid contact with eyes.

SPL UNCLASSIFIED 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 blood. This can occur even if you have used this product before. Stop use and seek immediate 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

SPL UNCLASSIFIED SECTION

Allergy alert:Do not use this product if you have a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
  • children under 2 years of age: do not use

Other Information

OTHER SAFETY INFORMATION

  • Do not use if packet is torn, cut, or opened
  • Store at room temperature, 15º to 30ºC (59º to 86ºF)
  • Avoid contact with eyes

Inactive ingredients

INACTIVE INGREDIENT SECTION

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-456-7077

Principal Display Panel - Safetec Oral Pain Relief Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-800-1

Safetec

First Aid

Oral Pain Relief

Fast mouth sore relief for:

Canker Sores

Gum Pain

Toothache

Dental Work

Reorder No. 53117

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - Safetec Oral Pain Relief Carton Label
Principal Display Panel - Safetec Oral Pain Relief Carton Label

Principal Display Panel - Safetec Oral Pain Relief Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

Oral Pain Relief

0.75 g (1/38 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - Safetec Oral Pain Relief Packet Label
Principal Display Panel - Safetec Oral Pain Relief Packet Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248280benzocaine 20 % Dental CreamPSN4
248280benzocaine 200 MG/ML Oral CreamSCD4
248280benzocaine 20 % Dental CreamSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8100-1Pain Relief0.75 g in 1 PACKETLIQUID0.754
61010-8100-1Pain Relief144 in 1 BOXLIQUID1444
61010-8100-2Pain Relief0.5 g in 1 PACKETLIQUID0.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8100PAIN RELIEF (BENZOCAINE) LIQUID [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 3 package rows20240217_de84e598-d047-4fae-b2ed-155a3788bc6f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW52
benzocaineACTIVE MOIETYU3RSY48JW52
peppermint oilINACTIVE INGREDIENTAV092KU4JH2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQ2
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TY2
sorbic acidINACTIVE INGREDIENTX045WJ989B2

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
61010-810061010-8100-2, 61010-8100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
PEPPERMINT OILAV092KU4JHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBIC ACIDX045WJ989BIACT
BENZOCAINEU3RSY48JW5ACTIB

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+dosage form
6 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
15 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route
6 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii+route
15 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
15 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+dosage form
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+dosage form
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route
6 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route
6 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii+route
6 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
saccharin sodium dihydrateSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route
15 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
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
ndc (package): 61010-8100-2
ndc (package): 61010-8100-1
ndc (product): 61010-8100
ndc11 (package): 61010810002
ndc11 (package): 61010810001
spl id: 11867852-2084-bc57-e063-6394a90a45da
spl set id: de84e598-d047-4fae-b2ed-155a3788bc6f

Reported adverse events (FAERS/openFDA)#

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