Poly-i Nextgen Formulation

Poly-i Nextgen Formulation
SPL v1
SPL
SPL Set ID cfb17f74-d08b-0ef7-e053-2995a90a0d19
Route
ORAL
Published
Effective Date 2021-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.6 mg) Thymol (0.64 mg) Eucalyptol (0.92 mg) Menthol, Unspecified Form (0.42 mg)
Inactive Ingredients
.iota.-carrageenan Peppermint Oil Sodium Benzoate Water Xylitol Benzoic Acid Anhydrous Citric Acid Sorbitol Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-11-05

Description

Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%

Purpose

Antiplaque/Antigingivitis


Medication Information

Purpose

Antiplaque/Antigingivitis

Description

Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%

Uses

Helps Prevent and Reduce

  • Plaque
  • Gingivitis
Purposes

Antiplaque/Antigingivitis

Warnings

Do not use in children under 12 years of age.

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.

Do not swallow

Other Information
  • Store at room temperature
  • Cold weather may cloud this product, its antiseptic properties are not affected.
  • Do not Use If Seal Cap Is Broken or Missing
Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

Alcohol (26.9%), Benzoic Acid, Citric Acid Anhydrous, Iota-Carrageenan, Peppermint Oil, Sodium Benzoate, Sorbitol, Water and Xylitol Crystalline

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children

Questions/drug Facts Back Label


Structured Label Content

Uses

Helps Prevent and Reduce

  • Plaque
  • Gingivitis
Purposes

Antiplaque/Antigingivitis

Warnings

Do not use in children under 12 years of age.

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.

Do not swallow

Other Information
  • Store at room temperature
  • Cold weather may cloud this product, its antiseptic properties are not affected.
  • Do not Use If Seal Cap Is Broken or Missing
Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

Alcohol (26.9%), Benzoic Acid, Citric Acid Anhydrous, Iota-Carrageenan, Peppermint Oil, Sodium Benzoate, Sorbitol, Water and Xylitol Crystalline

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children

Questions/drug Facts Back Label (Questions/Drug Facts-Back Label)


Advanced Ingredient Data


Raw Label Data

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