Orca Pain Reliever Putty With Menthol

Orca Pain Reliever Putty With Menthol
SPL v3
SPL
SPL Set ID 188cb01a-3d0f-43d9-983e-6475c0c5b06e
Route
ORAL
Published
Effective Date 2022-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8.4 mg)
Inactive Ingredients
Cardamom Oil Chamomile Cinnamon Oil Clove Oil Glycerin Guaiacol Maltodextrin Safflower Oil Tea Tree Oil Xanthan Gum Xylitol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-09-15 Until 2024-12-20

Description

Menthol 1.6%

Purpose

oral pain reliever


Medication Information

Purpose

oral pain reliever

Description

Menthol 1.6%

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: 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.
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 1.6%

Other Information
  • Do not use if outer package is broken, cut or torn.
Inactive Ingredients

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

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 001 01


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: 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.
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 1.6%

Other Information (Other information)
  • Do not use if outer package is broken, cut or torn.
Inactive Ingredients (Inactive ingredients)

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

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 001 01 (Package Labeling: 82939-001-01)


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