Label: TRISEPTIN WATER AIDED- alcohol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70472-102-32 - 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 September 12, 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
- Uses
- Warnings
- Do not use:
- Stop use and ask doctor if:
- Keep out of reach of children.
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Directions
- 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 the procedure to just below the elbows.
- Rinse completely.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 70472-102-32
Triseptin ®
Ethyl alcohol 70% v/v
WATER-AIDED
Surgical Hand Scrub
Alcohol with Persistence™Directions
- 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 the procedure to just below the elbows.
- Rinse completely.
Warnings
Flammable, keep away from fire or flame.
For external use only.
Do not use:- if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
- or on or near the eyes, mucous membranes, genital skin, or mouth. If product gets into the eyes, flush immediately with water.
- Avoid contact with broken skin.
Stop use and ask doctor if:
- irritation and redness develop
- condition persists for more than 72 hours.
Read Drug Facts Before Use.
32 fl oz (1 qt)
(946 ml)
140895-0417BD
REORDER NO. 0064-1030-32
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRISEPTIN WATER AIDED
alcohol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70472-102 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:70472-102-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/25/2017 Labeler - DFB Technology Ltd (965516164) Establishment Name Address ID/FEI Business Operations DPT Laboratories, Ltd. 832224526 manufacture(70472-102)