W1120 - TRACHEOSTOMY CARE PACK- anesthesia conduction kit   
Smiths Medical ASD, Inc.

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W1120 - Tracheostomy Care Pack

Hydrogen Peroxide USP 3%


Purpose
Antiseptic

For external use only.


Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • infection occurs
  • redness, irritation, swelling or pain persists or increases

Keep out of reach of children. In case of accidental ingestions, seek professional assistance or consult a poison control center immediately.

Questions or comments?1 800 760-3236 (Monday-Friday 8:30 AM-5:00 PM EST)

Apply locally as needed.

  • water

Topical anti-infective

Hydrogen Peroxide Packet

DR021-Hydrogen Peroxide Label.jpg

W1120 - TRACHEOSTOMY CARE PACK 
anesthesia conduction kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-0124
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-0124-420 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE 30 mL
Part 1 of 1
APLICARE HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Item Code (Source)NDC:52380-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0013-130 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/1983
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501701/30/200711/04/2019
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.081068252manufacture, repack

Revised: 11/2019
Document Id: 7f0848db-27fa-4e2f-85b1-4eca5239c823
Set id: 832c1535-e2fd-47fb-b243-8ae2776b1f1c
Version: 2
Effective Time: 20191104
 
Smiths Medical ASD, Inc.