Gurunanda Oral Pain Relief Rinse Sensitive

Gurunanda Oral Pain Relief Rinse Sensitive
SPL v3
SPL
SPL Set ID 3b8f3562-0e46-bea4-e063-6294a90adb71
Route
ORAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (15 mg)
Inactive Ingredients
Zanthoxylum Armatum Fruit Thyme Oil .alpha.-tocopherol, D- Cholecalciferol Mentha Piperita (peppermint) Oil Tea Tree Oil Myrrh Oil Caprylic/capric/lauric Triglyceride Clove Oil Spearmint Oil Menaquinone-7 Salvadora Persica Whole Copaifera Officinalis (balsam Copaiba) Resin Curcuma Zedoaria Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-04

Description

Menthol 1.5%


Medication Information

Description

Menthol 1.5%

Uses
  • For temporary pain relief due to minor irritation or injury of the mouth and gums resulting from:
  • Dental procedures
  • Orthodontic appliances
  • Dentures
  • Canker Sores
  • Other minor irritations of the mouth and gums
Section 55105-1

Oral Analgesic

Section 55106-9

Menthol 1.5%

Warnings

Warnings

Directions

Adults and children 6 years of age and older: Pour 10 mL into the measuring cup. Swish, gargle, push between teeth, or allow to remain in place for at least 2 minutes. Do not swallow. Spit out into a trash can. Use up to twice daily, or as directed by a dentist or doctor. Brush your teeth after use.

Children under 12 years of age: Should be supervised in the use of this product.

Children under 6 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.

Other Information
  • Do not use if pritned neck seal is broken or missing
  • Store in a cool place, away from heat and direct sunlight
Inactive Ingredients

Caprylic/Capric/Lauric Triglyceride, Clove (Eugenia caryophyllus) Oil, Peppermint (Mentha piperita) Oil, Spearmint (Mentha spicata) Oil, Winged Prickly Ash (Zanthoxylum alatum) Oil, Copaiba Balsam (Copaifera officinalis) Oil, Myrrh (Commiphora myrrha) Oil, Tea Tree (Melaleuca alternifolia) Oil, Thyme (Thymus zygis) Oil, White Tumeric (Curcuma zedoaria) Oil, D-Alpha-Tocopherol (Vitamin E), Miswak (Salvadora persica) Extract, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)

Principal Display Panel

When Using This Product

use only as directed. Read and follow all directions and warnings on this label.

  • Do not swallow
  • Do not exceed recommended dosage.
Stop Use and Ask Doctor If
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever devleops
  • sore mouth symptoms do not improve in 7 days
Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).


Structured Label Content

Uses
  • For temporary pain relief due to minor irritation or injury of the mouth and gums resulting from:
  • Dental procedures
  • Orthodontic appliances
  • Dentures
  • Canker Sores
  • Other minor irritations of the mouth and gums
Section 55105-1 (55105-1)

Oral Analgesic

Section 55106-9 (55106-9)

Menthol 1.5%

Warnings

Warnings

Directions

Adults and children 6 years of age and older: Pour 10 mL into the measuring cup. Swish, gargle, push between teeth, or allow to remain in place for at least 2 minutes. Do not swallow. Spit out into a trash can. Use up to twice daily, or as directed by a dentist or doctor. Brush your teeth after use.

Children under 12 years of age: Should be supervised in the use of this product.

Children under 6 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.

Other Information (Other information)
  • Do not use if pritned neck seal is broken or missing
  • Store in a cool place, away from heat and direct sunlight
Inactive Ingredients (Inactive ingredients)

Caprylic/Capric/Lauric Triglyceride, Clove (Eugenia caryophyllus) Oil, Peppermint (Mentha piperita) Oil, Spearmint (Mentha spicata) Oil, Winged Prickly Ash (Zanthoxylum alatum) Oil, Copaiba Balsam (Copaifera officinalis) Oil, Myrrh (Commiphora myrrha) Oil, Tea Tree (Melaleuca alternifolia) Oil, Thyme (Thymus zygis) Oil, White Tumeric (Curcuma zedoaria) Oil, D-Alpha-Tocopherol (Vitamin E), Miswak (Salvadora persica) Extract, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)

Principal Display Panel

When Using This Product (When using this product)

use only as directed. Read and follow all directions and warnings on this label.

  • Do not swallow
  • Do not exceed recommended dosage.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever devleops
  • sore mouth symptoms do not improve in 7 days
Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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