Label: ZURAGARD BLUE- isopropyl alcohol solution
- NDC Code(s): 49823-100-01, 49823-100-02
- Packager: Zurex Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient – 10.5 mL Applicator
- Purpose – 10.5 mL Applicator
- Uses – 10.5 mL Applicator
-
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.
-
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 cm2) - ▪
-
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
- Other information – 10.5 mL Applicator
- Inactive ingredients – 10.5 mL Applicator
- Questions? – 10.5 mL Applicator
- Active ingredient – 26 mL Applicator
- Purpose – 26 mL Applicator
- Uses – 26 mL Applicator
-
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.
-
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 cm2) - ▪
-
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
- Other information – 26 mL Applicator
- Inactive ingredients – 26 mL Applicator
- Questions? – 26 mL Applicator
-
Principal Display Panel – 10.5 mL Applicator Label
Single Use
NDC 49823-100-01ZuraGardTM
Isopropyl Alcohol (70% v/v) Solution
Patient Preoperative Skin PreparationNon-sterile Solution
Applicator is sterile if package is intact
Surgical Solution
For head, neck, and small prep areasBLUE
10.5 mL (0.36 fl oz) APPLICATORProfessional Use Only
Do not reuse
Not made with natural rubber latexWarning
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 53562Label
-
Principal Display Panel – 26 mL Applicator Label
Single Use
NDC 49823-100-02ZuraGardTM
Isopropyl Alcohol (70% v/v) Solution
Patient Preoperative Skin PreparationNon-sterile Solution
Applicator is sterile if package is intact
Surgical Solution
For large prep areas below the neckBLUE
26 mL (0.9 fl oz) APPLICATORProfessional Use Only
Do not reuse
Not made with natural rubber latexWarning
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 53562Label
-
INGREDIENTS AND APPEARANCE
ZURAGARD BLUE
isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49823-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLENE BLUE (UNII: T42P99266K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49823-100-01 25 in 1 CARTON 02/27/2023 1 10.5 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:49823-100-02 25 in 1 BOX 02/27/2023 2 26 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA210872 02/27/2023 Labeler - Zurex Pharma, Inc. (043472453) Establishment Name Address ID/FEI Business Operations ExxonMobil 037961513 API MANUFACTURE(49823-100) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 MANUFACTURE(49823-100) , ANALYSIS(49823-100) Establishment Name Address ID/FEI Business Operations Isomedix Operations Inc. 080419356 STERILIZE(49823-100)
