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Product NDC Code | 17271-107 | ||||
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Drug Name | Bd e-z scrub 107 |
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Type | Brand | ||||
Pharm Class | Decreased Cell Wall Integrity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 211365, 1233682 |
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Application Number | ANDA072525 | ||||
Labeler Name | Becton Dickinson and Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 4% Chlorhexidine gluconate w/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions wet hands and forearms to the elbows with warm water use nail cleaner and apply scrub solution from sponge side work up lather scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side rinse with warm water repeat scrub for 3 more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds. rinse hands and arms thoroughly dry thoroughly
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C red #40, hydrochloric acid, lauramide DEA, nonoxynol-12, peg-6000 distearate, peg-75 lanolin, purified water USP, sodium hydroxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use preoperative cleaning of healthcare personnel arms and hands.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.BD E-Z Scrub 107 chlorhexidine gluconate FD&C RED NO. 40 HYDROCHLORIC ACID LAURIC DIETHANOLAMIDE NONOXYNOL-12 PEG-150 DILAURATE PEG-75 LANOLIN WATER SODIUM HYDROXIDE CHLORHEXIDINE GLUCONATE CHLORHEXIDINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – Carton Label BD BD E-Z Scrub™ 107 Surgical Scrub Brush/Sponge and Nail Cleaner with 4% Chlorhexidine Gluconate 4% CHG CONTAINS: 30 NOTE: SEE BACK PANEL FOR EASY INSTRUCTIONS REF 371073 NDC 17271-107-03 U.S. Patent 5, 164, 107 Principal Display Panel – Carton Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use as a preoperative skin preparation of the face or head in eyes, ears and mouth if you have a sensitivity to chlorhexidine gluconate or its components.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information avoid excessive heat 40°C (104°F) discard after single use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. MST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with meninges chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water. Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Do not use as a preoperative skin preparation of the face or head in eyes, ears and mouth if you have a sensitivity to chlorhexidine gluconate or its components. When using this product avoid contact with meninges chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water. Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API