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| Product NDC Code | 53462-705 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Chlorhexidine gluconate |
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| Type | Generic | ||||||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CLOTH | ||||||||
| RxCUI drug identifier | 846127 | ||||||||
| Application Number | NDA021669 | ||||||||
| Labeler Name | Sage Products LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.2% CHLORHEXIDINE GLUCONATE CLOTH Active Ingredient Purpose Chlorhexidine Gluconate 2% Solution Antiseptic
| Chlorhexidine Gluconate 2% Solution | Antiseptic |
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 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 cm 2 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 cm 2 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, nonoxynol-9, polysorbate 20, propylene glycol, USP purified water cloth: polyester
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.Uses helps reduce bacteria that can potentially cause skin infection for preparation of skin prior to surgery
Spl product data elements
Usually a list of ingredients in a drug product.CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE WATER NONOXYNOL-9 POLYSORBATE 20 DIMETHICONE 350 PROPYLENE GLYCOL ALOE VERA LEAF GLYCERIN GLUCONOLACTONE 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.2 pack 9705 film 9705 inner carton
3 x 2 packs 9707 film 9707 inner carton
6 pack 9717 film 9717 inner carton
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, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll-free 800-323-2220 (Monday to Friday 8 AM - 5 PM CST) www.sageproducts.com DO NOT FLUSH CLOTHS Not made with natural rubber latex Patents: www.sageproducts.com/patents
Storage and handling
Information about safe storage and handling of the drug product.Other information store product flat store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
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 Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar punctures 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 chlorhexidine is 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 irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
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