Private Label Povidone Iodine Gargle 0.5%

Private Label Povidone Iodine Gargle 0.5%
SPL v5
SPL
SPL Set ID a7b9ad55-cfeb-6066-e053-2a95a90af975
Route
TOPICAL
Published
Effective Date 2020-06-10
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 2020-06-10

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

For the temporary relief of occasional sore throat.

Section 42229-5

Drug Facts

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Directions

DO NOT SWALLOW

Adults and children 12 years and older:

  • Gargle with 10mL full strength for 30 seconds, then spit out.
  • Use only with dosing cup provided.
  • Use up to 4 times daily.

Children under 12:

  • Do not use.
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.
Purdue Gargle Label

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.
If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children.

In case more than used for gargling is swallowed, get medical help or contact a Poison Control Center immediately.

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 the temporary relief of occasional sore throat.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antiseptic

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Directions

DO NOT SWALLOW

Adults and children 12 years and older:

  • Gargle with 10mL full strength for 30 seconds, then spit out.
  • Use only with dosing cup provided.
  • Use up to 4 times daily.

Children under 12:

  • Do not use.
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.
Purdue Gargle Label

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.
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 gargling is swallowed, get medical help or contact a Poison Control Center immediately.

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.


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