Prevail One Step
Dosage form: gel
Ingredients: POVIDONE-IODINE 5mg in 1mL, ALCOHOL 0.62mL in 1mL
Labeler: Productos Urologos de Mexico, S.A. de C.V.
NDC Code: 57613-008
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Ethanol 62% (v/v)
Povidone-Iodine USP 5.0% (0.5% available iodine)
Antiseptic
Antiseptic
For preparation of the patient’s skin prior to surgery. Helps reduce bacterial that potentially can cause skin infection.
For external use only.
Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:
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- solution contains alcohol and gives off flammable vapors.
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- do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
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- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
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- Do not allow to pool
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- Remove wet materials from prep area
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- If prep accidentally drips into hair, allow to dry completely
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- on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level.
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- on iodine sensitive patients
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- on open skin wounds or as a general skin cleanser
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- in the eyes or for prepping mucous membranes
use in well ventilated area.
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
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- to reduce risk of fire the following strategies are recommended:
- ∘
- at the end of prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
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- use in a well ventilated area
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- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
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- do not allow solution to pool
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- tuck prep towels to absorb solution, and then remove
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- remove wet materials from prep area
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- drape after solution is completely dry
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- Hold the bottle in an upright position
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- Twist the applicator head in the direction of the arrow until it stops
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- Firmly push the applicator head down into the bottle until a snap is heard
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- Invert bottle and gently squeeze to dispense solution
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- Once applicator sponge has been primed with solution it is not necessary to continue to squeeze the bottle
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- When applicable, press cotton-tipped swab securely against impregnated applicator head to wet, then clean umbilicus
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- Apply thin, even coat to operative site
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- If applying prep to a tight area (e.g., neck, skin folds), insert prep towels underneath to absorb excess solution
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- Remove any excess prep with absorbent towels or gauze
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- Discard prepping materials, including solution soaked materials
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- Wait until prep is dry (3 minutes or more) on skin before draping or using ignition sources
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- Remove with soap and water
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- Store at USP room temperature, 20-25°C (66-77°F)
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- Avoid excessive heat (not to exceed 104°F/40°C)
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- Citric Acid
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- Glycerin
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- Hydroxypropylcellulose
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- Nonoxynol-10
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- Simethicone
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- Sodium Hydroxide
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- USP purified water
call: 1-800-523-0502 (M-F 8 AM-5 PM CST)
Label
| PREVAIL ONE STEP
povidone-iodine and alcohol gel |
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| Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219) |
| Registrant - CareFusion 213 LLC (826496312) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Productos Urologos de Mexico, S.A. de C.V. | 812552219 | LABEL(57613-008), PACK(57613-008) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
