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FDA LABEL MFR: Halodine LLC

Povidone-iodine 1.75 % (titratable Iodine 0.175 % ) Topical Solution

Povidone-Iodine USP, 1.75%

(0.175% Available Iodine)

Antiseptic

INDICATIONS AND USAGE

Oral Antiseptic First aid to help prevent infection in minor oral irritation caused by dental procedures

WARNINGS

For external use only.

Do not use • If allergic to iodine •  In the eyes •  On children less than 3 years old •  For more than 7 days unless directed by a dentist or doctor

When using this product: Do not swallow

Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

For oral antisepsis in adults and children 3 years of age and older:

Twist off the narrow end of single ampoule. Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml. Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds. Slightly lift chin and tilt head back to gargle, then spit out.

Children under 3 years of age: Consult a dentist or doctor

Single use only; do not reuse Not made with natural rubber latex Store at room temperature; avoid excessive heat

hydroxyethylcellulose, purified water

Helps Reduce Risk of Infection

4-Hour Formula

Non-Sterile Antiseptic Solution

PATENT PENDING

Manufactured in the U.S.A. for Halodine LLC

111 NE 1st St, Ste 806, Miami, FL 33132

halodine.com

Packaging