Orca Complete Menthol Oral Pain Reliever

Orca Complete Menthol Oral Pain Reliever
SPL v3
SPL
SPL Set ID 99990e27-d66b-4d61-97f2-6a76066eb8b8
Route
ORAL
Published
Effective Date 2022-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (20 mg)
Inactive Ingredients
Clove Oil Glycerin Guaiacol Oregano Leaf Oil Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-09-15 Until 2025-08-31
Description

Menthol 2%

Purpose

oral pain reliever

Medication Information

Purpose

oral pain reliever

Description

Menthol 2%

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

Directions
  • Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal.
  • Children under 12 years of age should be supervised in use of this product.
  • Children under 12 years of age: Consult a dentist or doctor.
Do Not Use
  • this product for more than 7 days unless directed by a dentist or doctor.
Drug Facts

Questions?

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

Active Ingredient

Menthol 2%

Other Information
  • Do not use if tamperproof seal is not intact at time of first use.
Inactive Ingredients

Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.

When Using This Product
  • do not exceed recommended dosage.
Stop Use and Ask A Doctor If
  • 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,

ask a health professional before use.

Keep Out of Reach of Children.

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

Package Labeling: 82939 000 02

Structured Label Content

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

oral pain reliever

Warnings

Directions
  • Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal.
  • Children under 12 years of age should be supervised in use of this product.
  • Children under 12 years of age: Consult a dentist or doctor.
Do Not Use (Do not use)
  • this product for more than 7 days unless directed by a dentist or doctor.
Drug Facts

Questions?

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

Active Ingredient (Active ingredient)

Menthol 2%

Other Information (Other information)
  • Do not use if tamperproof seal is not intact at time of first use.
Inactive Ingredients (Inactive ingredients)

Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.

When Using This Product (When using this product)
  • do not exceed recommended dosage.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package Labeling: 82939 000 02 (Package Labeling: 82939-000-02)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:28.683185 · Updated: 2026-03-14T23:02:03.345038