Label: TRISEPTIN- alcohol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70472-101-04 - Packager: DFB Technology Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 30, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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Uses
Surgical Hand Scrub
- Significantly reduces the number of microorganisms on the hands, forearms and body prior to surgery or patient care.
Patient Preoperative Skin Preparation
- For preparation of the skin prior to surgery or an injection.
- Helps reduce bacteria that can potentially cause skin infection.
- Warnings
- Do not Use:
- Stop use and ask a doctor if:
- Keep out of reach of chipdren.
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Directions
Surgical Hand Scrub
- Clean under nails with a nail pick. Nails should be maintained with a 1 mm free edge.
- Wet hands and forearms.
- Dispense palmful (approx. 7 ml) of TRISEPTIN ® Scrub into the palm of one hand.
- Twist fingertips of the opposite hand, working TRISEPTIN under the nails.
- Transfer TRISEPTIN to the opposite hand and repeat with fingertips of the other hand.
- Rub TRISEPTIN over the hands and up the forearms to just past the elbow, paying particular attention to the nails, cuticles and interdigital spaces for 90 seconds.
- Rinse and repeat.
- Rinse completely.
Patient Preoperative Skin Preparation
- Apply to cleanse the surgical site and surrounding area 12 hours and 6 hours prior to surgery.
- Clean the surgical area.
- Place a palmful (approx. 7 ml) of TRISEPTIN to the surgical site and surrounding area and rub for 90 seconds paying particular attention to the surgical area.
- Rinse and repeat.
- Rinse completely.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 70472-101-04
Triseptin®
Ethyl alcohol 70% v/v
Hand & Body AntisepticSurgical Hand Scrub
- Used by surgeons in hospital operating rooms
Patient Preoperative Skin Preparation
- Helps reduce bacteria that can potentially cause skin infection
- Alcohol and other skin-conditioning ingredients
- Fast antibacterial action
4 fl oz
(118 ml)
140839-1116BD
REORDER NO. 0064-1050-04PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRISEPTIN
alcohol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70472-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCAMINE OXIDE (UNII: QWA2IZI6FI) GLYCERYL LAURATE (UNII: Y98611C087) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PYRITHIONE ZINC (UNII: R953O2RHZ5) Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70472-101-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/15/2017 Labeler - DFB Technology Ltd (965516164) Establishment Name Address ID/FEI Business Operations DPT Laboratories 832224526 manufacture(70472-101)