NDC 11084-128 Bactoshield Chg

Chlorhexidine Gluconate

NDC Product Code 11084-128

NDC 11084-128-03

Package Description: 118 mL in 1 BOTTLE

NDC 11084-128-08

Package Description: 3785 mL in 1 BOTTLE

NDC 11084-128-24

Package Description: 946 mL in 1 BOTTLE

NDC 11084-128-34

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Bactoshield Chg with NDC 11084-128 is a a human over the counter drug product labeled by Sc Johnson Professional Usa, Inc.. The generic name of Bactoshield Chg is chlorhexidine gluconate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sc Johnson Professional Usa, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Bactoshield Chg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHLORHEXIDINE GLUCONATE 40 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • COCAMINE OXIDE (UNII: QWA2IZI6FI)
  • GLUCONIC ACID (UNII: R4R8J0Q44B)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • QUATERNIUM-33 (UNII: XPS4174QZJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sc Johnson Professional Usa, Inc.
Labeler Code: 11084
FDA Application Number: NDA019258 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bactoshield Chg Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredient

Chlorhexidine gluconate solution, 4%

Purposes

Surgical hand scrubHealthcare personnel handwashSkin wound and general skin cleanser

Uses

  • Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient carehealthcare personnel handwash: handwash to help reduce bacteria that potentially can cause diseaseskin wound and general skin cleanser: helps reduce bacteria on the skin

Warnings

For external use only

Allergy Alert

  • This product may cause a severe allergic reaction. Symptoms may include:wheezing/difficulty breathingshockfacial swellinghivesrashIf an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

  • If you are allergic to chlorhexidine gluconate or any other ingredient in this preparationas a patient preoperative skin preparation (especially on the head or face)in contact with meningesin the genital area

When Using This Product

  • Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.if contact occurs, rinse with cold water right awaywounds which involve more than the superficial layers of the skin should not be routinely treatedrepeated general skin cleansing of large body areas should not be done except when an underlying condition makes it necessary to reduce the bacterial population of the skin

Otc - Stop Use

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Otc - 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.

Directions

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.use full strengthdo not dilute

Surgical Hand Scrub

  • Remove jewelrywet hands and forearms with water and apply 5 mL of the productwash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spacesrinse thoroughly with waterwash for an additional 3 minutes with 5 mL of the product and rinse under running waterdry thoroughly

Healthcare Personnel Handwash

  • Wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 secondsrinse and dry thoroughly

Skin Wound And General Skin Cleanser

  • Thoroughly rinse the area to be cleansed with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.rinse again thoroughly

Other Information

  • Store between 20-25°C (68-77°F)avoid excessive heat (above 104°F/40°C)for additional information, see Safety Data Sheet (SDS)if swallowed get medical help or contact a Poison Control Center immediately

Inactive Ingredients

Cocamide DEA, cocamine oxide, fragrance, gluconic acidcontains one or more of these ingredients, gluconolactone, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

* Please review the disclaimer below.