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| Product NDC Code | 49823-100 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zuragard blue |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 808520 | ||||||
| Application Number | NDA210872 | ||||||
| Labeler Name | Zurex Pharma, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient – 10.5 mL Applicator Isopropyl alcohol 70% v/v
Active ingredient – 26 mL Applicator Isopropyl alcohol 70% v/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions – 10.5 mL Applicator Follow all directions for use ▪ use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. ▪ do not use when the sponge is already wet upon opening the package ▪ discard the applicator after a single use along with any portion of the solution which is not required to cover the prepped area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: ▪ use in well-ventilated area ▪ do not microwave or heat the solution applicator ▪ apply to clean, completely dry, residue-free, intact skin ▪ when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: ▪ remove applicator from package; do not touch sponge ▪ hold the applicator with the sponge down. Depress the end cap/button to release the antiseptic, solution will flow into the sponge. When Applying Solution: ▪ completely wet the treatment area with antiseptic ▪ dry surgical sites (such as the abdomen or arm): use repeated back-and-forth strokes for 30 seconds ▪ moist surgical sites (such as inguinal fold): use repeated back-and-forth strokes for 2 minutes ▪ maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm 2 ) ▪ do not allow solution to pool; tuck prep towels to absorb solution, and then remove ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. After Applying Solution: ▪ to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) While Waiting for Solution to Completely Dry: ▪ do not drape or use ignition source (e.g., cautery, laser) ▪ check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot or wipe away because it may remove solution from skin. ▪ remove wet materials from prep area. Replace if necessary. After Solution is Completely Dry: ▪ to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed ▪ if incise drapes are used, apply directly to dry prep ▪ apply dressing following standard practices
Directions – 26 mL Applicator Follow all directions for use ▪ use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. ▪ do not use when the sponge is already wet upon opening the package ▪ discard the applicator after a single use along with any portion of the solution which is not required to cover the prepped area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: ▪ use in well-ventilated area ▪ do not microwave or heat the solution applicator ▪ apply to clean, completely dry, residue-free, intact skin ▪ when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: ▪ remove applicator from package; do not touch sponge ▪ hold the applicator with the sponge down. Depress the end cap/button to release the antiseptic, solution will flow into the sponge. When Applying Solution: ▪ completely wet the treatment area with antiseptic ▪ dry surgical sites (such as the abdomen or arm): use repeated back-and-forth strokes for 30 seconds ▪ moist surgical sites (such as inguinal fold): use repeated back-and-forth strokes for 2 minutes ▪ maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm 2 ) ▪ do not allow solution to pool; tuck prep towels to absorb solution, and then remove ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. After Applying Solution: ▪ to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) While Waiting for Solution to Completely Dry: ▪ do not drape or use ignition source (e.g., cautery, laser) ▪ check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot or wipe away because it may remove solution from skin. ▪ remove wet materials from prep area. Replace if necessary. After Solution is Completely Dry: ▪ to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all wet materials are removed ▪ if incise drapes are used, apply directly to dry prep ▪ apply dressing following standard practices
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients – 10.5 mL Applicator citric acid, methylene blue, methylparaben, propylparaben, purified water USP, trisodium citrate
Inactive ingredients – 26 mL Applicator citric acid, methylene blue, methylparaben, propylparaben, purified water USP, trisodium citrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses – 10.5 mL Applicator ▪ for preparation of the skin prior to surgery ▪ helps reduce bacteria that potentially can cause skin infection
Uses – 26 mL Applicator ▪ for preparation of the skin prior to surgery ▪ helps reduce bacteria that potentially can cause skin infection
Purpose
Information about the drug product’s indications for use.Purpose – 10.5 mL Applicator Antiseptic
Purpose – 26 mL Applicator Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.ZuraGard Blue isopropyl alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL TRISODIUM CITRATE DIHYDRATE WATER ANHYDROUS CITRIC ACID METHYLENE BLUE METHYLPARABEN PROPYLPARABEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – 10.5 mL Applicator Label Single Use NDC 49823-100-01 ZuraGard TM Isopropyl Alcohol (70% v/v) Solution Patient Preoperative Skin Preparation Non-sterile Solution Applicator is sterile if package is intact Surgical Solution For head, neck, and small prep areas BLUE 10.5 mL (0.36 fl oz) APPLICATOR Professional Use Only Do not reuse Not made with natural rubber latex Warning Flammable Keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet material from prep area Manufactured for Zurex Pharma, Inc. Middleton, WI 53562 Label image-01
Principal Display Panel – 26 mL Applicator Label Single Use NDC 49823-100-02 ZuraGard TM Isopropyl Alcohol (70% v/v) Solution Patient Preoperative Skin Preparation Non-sterile Solution Applicator is sterile if package is intact Surgical Solution For large prep areas below the neck BLUE 26 mL (0.9 fl oz) APPLICATOR Professional Use Only Do not reuse Not made with natural rubber latex Warning Flammable Keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ do not use 26-mL applicator for head and neck surgery, or on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead. ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet material from prep area Manufactured for Zurex Pharma, Inc. Middleton, WI 53562 Label image-02
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser
Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information – 10.5 mL Applicator ▪ store between 15-30 o C (59-86 o F) ▪ avoid freezing and excessive heat above 40 o C (104 o F) ▪ the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove tint if desired.
Other information – 26 mL Applicator ▪ store between 15-30 o C (59-86 o F) ▪ avoid freezing and excessive heat above 40 o C (104 o F) ▪ the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove tint if desired.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? – 10.5 mL Applicator call 1-833-342-2798 (M-F 8AM-5PM CST). www.zurexpharma.com
Questions? – 26 mL Applicator call 1-833-342-2798 (M-F 8AM-5PM CST) www.zurexpharma.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings – 10.5 mL Applicator For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet materials from prep area Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. 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.
Warnings – 26 mL Applicator For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ do not use 26-mL applicator for head and neck surgery ▪ do not use on an area smaller than 8.4 in x 8.4 in. Use a smaller applicator instead. ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet materials from prep area Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API