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Generic: povidone-iodine is used for the treatment of Burns Dermatitis Herpetiformis Hypersensitivity Leg Ulcer Radiation Injuries Skin Diseases Staphylococcal Infections Surgical Wound Infection Thyroid Diseases Vasculitis

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Drug Facts

Active ingredient
Povidone-iodine, 0.5%(0.05% available iodine)

Purpose

Antiseptic

Uses

  • For the temporary relief of occasional sore throat

Warnings

SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor.

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 ingredientsin this product
  • if you have any thyroid conditions

When using this product

  • do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor
  • do not swallow
  • do not use with hydrogen peroxide

Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Otc - Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case more than used for gargling is accidentally swallowed, getmedical help or contact a Poison Control Center right away.

Directions

DO NOT SWALLOW Adults andchildren 12 years and older:
  • Gargle with 10 ml full strength for 30 seconds, then spitout
  • Use only with dosing cup provided
  • Use up to 4 times daily
Children under 12: Do not use.

Other Information

  • store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F)
  • may stain clothing or dental work
  • avoid contact with jewelry, especially silver

Inactive Ingredients

citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431 305586-0E

Package Label.principal Display Panel

BetadineGargle CartonNDC: 67618-181-08

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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