Betadine

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Betadine Recall

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Side Effects & Adverse Reactions

For external use only

Do not use

in the eyes
If you are allergic to povidone-iodine or any other ingredients in this preparation

When using this product

prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
in pre-operative prepping, avoid “pooling” beneath the patient

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

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

Do not use

in the eyes
If you are allergic to povidone-iodine or any other ingredients in this preparation

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Patient pre-operative skin preparation

for preparation of the skin prior to surgery
helps reduce bacteria that potentially can cause skin infection

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Betadine Manufacturers

Purdue Products Lp

Betadine | Purdue Products Lp

hold container about 4-6 inches from skin spray desired area n allow to dry may be bandaged replace cap after use

No Recall
Purdue Products Lp

Betadine | Purdue Products Lp

clean the operative site prior to surgery apply product and allow to dry may be covered with a bandage

No Recall
Alcon Laboratories, Inc.

Betadine | Alcon Laboratories, Inc.

While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided.

BETADINE® 5% Sterile Ophthalmic Prep Solution is used as

follows:

1. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze entire contents of bottle into a sterile prep cup.

2. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.

3. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.

4. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE® 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe.

5. After the BETADINE® 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.

No Recall
Rebel Distributors Corp

Betadine | Rebel Distributors Corp

While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided.

BETADINE® 5% Sterile Ophthalmic Prep Solution is used as

follows:

1. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze entire contents of bottle into a sterile prep cup.

2. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.

3. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.

4. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE® 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe.

5. After the BETADINE® 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.

No Recall
Purdue Products Lp

Betadine | Purdue Products Lp

tear slit; pull top of packette up and away, exposing pad use pad to swab area thoroughly repeat using the other side if necessary use one time only. Each packette contains 1 Swab Aid Antiseptic pad.

No Recall