{"active_ingredient":["Active ingredient – 10.5 mL Applicator Isopropyl alcohol 70% v/v","Active ingredient – 26 mL Applicator Isopropyl alcohol 70% v/v"],"do_not_use":["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"],"dosage_and_administration":["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"],"effective_time":"20241223","id":"f5f214bf-91d5-4c95-90d0-d85fea6e759e","inactive_ingredient":["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":["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"],"keep_out_of_reach_of_children":["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."],"openfda":{},"other_safety_information":["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."],"package_label_principal_display_panel":["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"],"purpose":["Purpose – 10.5 mL Applicator Antiseptic","Purpose – 26 mL Applicator Antiseptic"],"questions":["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"],"set_id":"a1a966b0-7e40-4d83-bcf9-dac0f43112da","spl_product_data_elements":["ZuraGard Blue isopropyl alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL TRISODIUM CITRATE DIHYDRATE WATER ANHYDROUS CITRIC ACID METHYLENE BLUE METHYLPARABEN PROPYLPARABEN"],"stop_use":["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."],"version":"3","warnings":["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."],"when_using":["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."]}