Label: ACL11CH NERVE BLOCK- kit
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
Updated April 14, 2014
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
For external use only. Flammable, keep away from fire or flame.
To reduce the risk of fire, PREP CAREFULLY:
solution contains alcohol and gives off flammable vapors
avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
do not allow solution to pool
remove wet materials from prep area
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
use in a well ventilated area
maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm2)
remove applicator from package; do not touch sponge
hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
completely wet the treatment area with antiseptic
dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds
moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACL11CH NERVE BLOCK
regional anesthesia kit kit
Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:55553-482 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:55553-482-02 30 in 1 CASE 1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 APPLICATOR 3 mL Part 1 of 1 CHLORAPREP ONE-STEP
chlorhexidine gluconate and isopropyl alcohol solution
Product Information Item Code (Source) NDC:54365-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.70 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54365-400-11 3 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020832 08/18/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K965017 01/14/2014 Labeler - Smiths Medical ASD, Inc. (137835299) Establishment Name Address ID/FEI Business Operations Smiths Medical ASD, Inc. 137835299 manufacture Establishment Name Address ID/FEI Business Operations CareFusion 213 LLC 830430778 manufacture