FDA.reportPublic FDA data

W1119 - Tracheostomy Care Pack

Manufacturer
Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2018-08-22
Label type
MEDICAL DEVICE
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:52:37

Label at a glance#

ProductW1119 - Tracheostomy Care Pack
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide USP 3%

Purpose
Antiseptic

WARNINGS SECTION

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.

OTC - QUESTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Apply locally as needed.

INACTIVE INGREDIENT SECTION

  • Water

INDICATIONS & USAGE SECTION

Topical anti-infective

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrogen Peroxide Packet

DR021-Hydrogen Peroxide Label.jpgDR021-Hydrogen Peroxide Label.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

W1119-AS10001126-001 REV 100.jpgW1119-AS10001126-001 REV 100.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0013-1ML - Milliliter52380-0013f923cd3a-05c1-4992-8cda-be97c9b3590512012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51688-012351688-0123-4
52380-001352380-0013-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsName fallback
generic name: HYDROGEN PEROXIDE
First ShieldHYDROGEN PEROXIDEEVER READY FIRST AID94307d2f-5366-4fdb-b919-4a8658dda0582026-08-03WarningsName fallback
generic name: HYDROGEN PEROXIDE
AEROAIDHYDROGEN PEROXIDEAero Healthcare US LLC52e527c5-2568-496e-b5df-df67f260c70f2026-07-24WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsName fallback
generic name: HYDROGEN PEROXIDE
HYDROGEN PEROXIDEHYDROGEN PEROXIDEMedical Chemical Corporationb1ce5858-36fe-70dc-e053-2995a90a59132026-07-02WarningsName fallback
generic name: HYDROGEN PEROXIDE
HYDROGEN PEROXIDEHYDROGEN PEROXIDEMedical Chemical Corporationf6d677b8-fa89-4efb-984a-fd98e3e590e82026-07-02WarningsName fallback
generic name: HYDROGEN PEROXIDE
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsName fallback
generic name: HYDROGEN PEROXIDE
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsName fallback
generic name: HYDROGEN PEROXIDE
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDETarget Corporation33591569-8c56-4721-9d14-d9696f93c7932026-04-30Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE
Oopsie 3 Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC50b0d82a-da2c-5fd0-e063-6294a90aa1652026-04-30WarningsName fallback
generic name: HYDROGEN PEROXIDE
Hydrogen PeroxideHYDROGEN PEROXIDERetail Business Services, LLC2cc09239-a1d4-4276-adc4-82fdc396e23a2026-04-29Warnings, Adverse reactionsName fallback
generic name: HYDROGEN PEROXIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.