ORCA Pain Reliever Putty with Menthol

Manufacturer
ORCA Products, LLC
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:47

Label at a glance#

ProductORCA Pain Reliever Putty with Menthol
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Dosage and administration

Adults and children 12 years of age and older: Allow product dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor Children under 12 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.6%

Purpose

OTC - PURPOSE SECTION

oral pain reliever

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • this product for more than 7 days unless directed by a dentist or doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Allow product dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor
  • Children under 12 years of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

  • Do not use if outer package is broken, cut or torn.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Cinnamomum Zeylanicum Bark Oil, Elettaria Cardamomum Seed Oil, Eugenol, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Guaiacol, Maltodextrin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Xanthan Gum, Xylitol

Questions?

OTC - QUESTIONS SECTION

1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)

Package Labeling: 82939-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

putty labelputty labelputty lid labelputty lid label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82939-001-01ORCA Pain Reliever Putty with Menthol1 in 1 PACKAGEPASTE13
82939-001-01ORCA Pain Reliever Putty with Menthol4.2 g in 1 JARPASTE4.23
82939-001-02ORCA Pain Reliever Putty with Menthol1 in 1 BLISTER PACKPASTE13
82939-001-02ORCA Pain Reliever Putty with Menthol7 g in 1 JARPASTE73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82939-001ORCA PAIN RELIEVER PUTTY WITH MENTHOL (MENTHOL) PASTE [ORCA PRODUCTS, LLC]3Current NDC, Legacy NDC, 4 package rows20231111_188cb01a-3d0f-43d9-983e-6475c0c5b06e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82939-00182939-001-01, 82939-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
ndc (package): 82939-001-02
ndc (package): 82939-001-01
ndc (product): 82939-001
ndc11 (package): 82939000102
ndc11 (package): 82939000101
spl id: 09ce4763-a8e6-7cff-e063-6294a90a851c
spl set id: 188cb01a-3d0f-43d9-983e-6475c0c5b06e

Reported adverse events (FAERS/openFDA)#

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