ZuraGard Clear

Manufacturer
Zurex Pharma, Inc. | ExxonMobil | Ferndale Laboratories, Inc. | Isomedix Operations Inc.
Effective date
2023-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:30

Label at a glance#

ProductZuraGard Clear
Active ingredientISOPROPYL ALCOHOL
Label structure18 sections

Indications and uses

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

Dosage and administration

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. Gett...

Label contents#

Full prescribing information#

Active ingredient – 10.5 mL Applicator

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v

Purpose – 10.5 mL Applicator

OTC - PURPOSE SECTION

Antiseptic

Uses – 10.5 mL Applicator

INDICATIONS & USAGE SECTION

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

Warnings – 10.5 mL Applicator

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions – 10.5 mL Applicator

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

  • store between 15-30oC (59-86oF)
  • avoid freezing and excessive heat above 40oC (104oF)

Inactive ingredients – 10.5 mL Applicator

INACTIVE INGREDIENT SECTION

citric acid, methylparaben, propylparaben, purified water USP, trisodium citrate

Questions? – 10.5 mL Applicator

OTC - QUESTIONS SECTION

call 1-833-342-2798 (M-F 8AM-5PM CST).
www.zurexpharma.com

Active ingredient – 26 mL Applicator

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v

Purpose – 26 mL Applicator

OTC - PURPOSE SECTION

Antiseptic

Uses – 26 mL Applicator

INDICATIONS & USAGE SECTION

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

Warnings – 26 mL Applicator

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions – 26 mL Applicator

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

  • store between 15-30oC (59-86oF)
  • avoid freezing and excessive heat above 40oC (104oF)

Inactive ingredients – 26 mL Applicator

INACTIVE INGREDIENT SECTION

citric acid, methylparaben, propylparaben, purified water USP, trisodium citrate

Questions? – 26 mL Applicator

OTC - QUESTIONS SECTION

call 1-833-342-2798 (M-F 8AM-5PM CST) www.zurexpharma.com

Principal Display Panel – 10.5 mL Applicator Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Single Use
NDC 49823-200-01

ZuraGardTM
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

CLEAR
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

image-01
image-01

Label

Principal Display Panel – 26 mL Applicator Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Single Use
NDC 49823-200-02

ZuraGardTM
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

CLEAR
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

image-02
image-02

Label

Products#

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DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49823-20049823-200-01, 49823-200-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
958ef9ef-88ef-4763-a457-6270d98a75b2f513404d-d6f3-4ce2-9576-db96bb634e292024-12-23WarningsExact identifier
spl set id: f513404d-d6f3-4ce2-9576-db96bb634e29

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.