Private Label Povidone Iodine Oral Rinse 0.5%

Private Label Povidone Iodine Oral Rinse 0.5%
SPL v4
SPL
SPL Set ID b83dbdd1-ff63-caf8-e053-2a95a90a5764
Route
TOPICAL
Published
Effective Date 2021-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (5 mg)
Inactive Ingredients
Menthol Saccharin Sodium Anhydrous Citric Acid Glycerin Sodium Hydroxide Water Propylene Glycol Peppermint

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-06

Description

Drug Facts

Purpose

Oral Antiseptic


Medication Information

Purpose

Oral Antiseptic

Description

Drug Facts

Use

For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.

Section 42229-5

Drug Facts

Warnings

Do not use this product

  • for more than 7 days unless directed by a dentist of doctor
  • in children under 12 years of age unless directed by a dentist or doctor
  • if you are allergic to povidone-iodine or any other ingredients in this product
  • if you have any thyroid conditions
Directions
  • Use full strength.
  • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
  • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
  • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
Active Ingredient

Povidone-Iodine 0.5%

(0.05% available iodine)

Other Information
  • Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F).
  • May stain clothing or dental work.
  • Avoid contact with jewelry, especially silver.
Inactive Ingredients

Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

Do Not Use This Product
  • For more than 7 days unless directed by a dentist or doctor.
  • If you are allergic to povidone-iodine or any other ingredients in this product.
  • If you have any thyroid conditions.
Purdue Oral Rinse Label

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children.

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

When Using This Product Do Not

Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.

Swallow.

Use with hydrogen peroxide.

Stop Use and Consult A Doctor If

Symptoms do not improve in 7 days.

Irritation, pain or redness persists or worsens.

Swelling, rash or fever develops.


Structured Label Content

Use

For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Oral Antiseptic

Warnings

Do not use this product

  • for more than 7 days unless directed by a dentist of doctor
  • in children under 12 years of age unless directed by a dentist or doctor
  • if you are allergic to povidone-iodine or any other ingredients in this product
  • if you have any thyroid conditions
Directions
  • Use full strength.
  • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
  • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
  • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
Active Ingredient

Povidone-Iodine 0.5%

(0.05% available iodine)

Other Information (Other information)
  • Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F).
  • May stain clothing or dental work.
  • Avoid contact with jewelry, especially silver.
Inactive Ingredients

Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

Do Not Use This Product (Do not use this product)
  • For more than 7 days unless directed by a dentist or doctor.
  • If you are allergic to povidone-iodine or any other ingredients in this product.
  • If you have any thyroid conditions.
Purdue Oral Rinse Label

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

When Using This Product Do Not (When using this product do not)

Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.

Swallow.

Use with hydrogen peroxide.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

Symptoms do not improve in 7 days.

Irritation, pain or redness persists or worsens.

Swelling, rash or fever develops.


Advanced Ingredient Data


Raw Label Data

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