2% Chlorhexidine Gluconate Cloth And 3m Skin And Nasal Antiseptic

2% Chlorhexidine Gluconate Cloth And 3m Skin And Nasal Antiseptic
SPL v1
SPL
SPL Set ID d36bf0aa-9dec-3328-cab8-8fc6748dafb3
Route
TOPICAL
Published
Effective Date 2012-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (500 mg) Iodine (5 mg)
Inactive Ingredients
Water Nonoxynol-9 Polysorbate 20 Dimethicone 350 Propylene Glycol Aloe Vera Leaf Glycerin Gluconolactone Lactic Acid Lauramidopropylamine Oxide Malic Acid Sodium Hydroxide Sodium Iodide Peg-100 Stearate Xylitol

Identifiers & Packaging

Marketing Status
NDA Active Since 2012-02-06

Description

Active ingredient chlorhexidine gluconate 2% solution Povidone-Iodine USP, 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

Directions

2% Chlorhexidine Gluconate Cloth

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.

To open package

  • holding top of package in one hand, lift flap on backside of package with other hand
  • grasp flap at top and pull down to tear flap away and expose foam
  • hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.

Or

  • using sterile scissors, cut off end seal of package
  • transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
  • use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.
  • dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
  • moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
  • discard each cloth after a single use
  • after package has been opened discard any unused cloths

Directions

3M Skin and Nasal Antiseptic

  • open package and remove bottle and swabs
  • unscrew cap by turning cap counter-clockwise

Skin Application:

  • Apply to clean dry skin.
  • Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
  • Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
  • Repeat steps 2 & 3 using second swab.
  • Allow prep solution to dry. Do not blot.

Nasal Application:

  • Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
  • Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
  • Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
  • Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
  • Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
  • Do not blow nose. If solution drips out of nose, it can be lightly dabbed with a tissue.
Description

Active ingredient chlorhexidine gluconate 2% solution Povidone-Iodine USP, 5%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Do not use

  • on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds or as a general skin cleanser
Section 50567-7

When using this product

  • keep out of eyes, ears, and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water.  Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Section 51727-6

Inactive ingredients

2% Chlorhexidine Gluconate Cloth

aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water



cloth: polyester

Inactive ingredients

3M Skin and Nasal Antiseptic

Lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol

Section 51945-4

2% Chlorhexidine Gluconate* Cloth

NDC 053462–705–23

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

chlorhexidine gluconate 2% solution

Povidone-Iodine USP, 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps reduce bacteria that can potentially cause skin infection
  • for preparation of skin prior to surgery
Dosage and Administration (34068-7)

Directions

2% Chlorhexidine Gluconate Cloth

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.

To open package

  • holding top of package in one hand, lift flap on backside of package with other hand
  • grasp flap at top and pull down to tear flap away and expose foam
  • hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.

Or

  • using sterile scissors, cut off end seal of package
  • transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
  • use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.
  • dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
  • moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
  • discard each cloth after a single use
  • after package has been opened discard any unused cloths

Directions

3M Skin and Nasal Antiseptic

  • open package and remove bottle and swabs
  • unscrew cap by turning cap counter-clockwise

Skin Application:

  • Apply to clean dry skin.
  • Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
  • Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
  • Repeat steps 2 & 3 using second swab.
  • Allow prep solution to dry. Do not blot.

Nasal Application:

  • Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
  • Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
  • Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
  • Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
  • Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
  • Do not blow nose. If solution drips out of nose, it can be lightly dabbed with a tissue.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Do not use

  • on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds or as a general skin cleanser
Section 50567-7 (50567-7)

When using this product

  • keep out of eyes, ears, and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water.  Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Section 51727-6 (51727-6)

Inactive ingredients

2% Chlorhexidine Gluconate Cloth

aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water



cloth: polyester

Inactive ingredients

3M Skin and Nasal Antiseptic

Lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol

Section 51945-4 (51945-4)

2% Chlorhexidine Gluconate* Cloth

NDC 053462–705–23

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

chlorhexidine gluconate 2% solution

Povidone-Iodine USP, 5%


Advanced Ingredient Data


Raw Label Data

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