Luxury

Manufacturer
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:54

Label at a glance#

ProductLuxury Antiseptic
Active ingredientHYDROGEN PEROXIDE
Label structure11 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 3%

Purpose

OTC - PURPOSE SECTION

first aid antiseptic / oral debriding agent

INDICATIONS & USAGE SECTION

Uses *First aid to help prevent the risk of infection in minor cuts, scrapes, and burns. *Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

Ask doctor 

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Do not use

OTC - DO NOT USE SECTION

Do not use *in the eyes or apply over large areas of the body. *longer than one week.

DOSAGE & ADMINISTRATION SECTION

Directions For use as a first aid antiseptic:

  • Clean affected area.
  •  apply small amount of product on affected area 1-3 times a day.
  • may be covered with a sterile bandage. 
  • For use as an oral debriding agent (oral rinse): 
  • adults and children 2 years of age and over
  • mix with an equal amount of water.
  • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow. 
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
  • children under 12 years should be supervised in the use of this product. 
  • children under 2 years of age: consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

  • Keep tightly closed and in a dark place at room temperature. 
  • Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENT SECTION

Inactive ingredient purified water

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN2
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD2
91349hydrogen peroxide 3 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76772-023-172023-01-30C16284748780-1f386c64a-0e86-0266-e053-dadaa90a7c1aLuxury 3% Hydrogen Peroxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-023-17LuxuryAntiseptic177 mL in 1 BOTTLE, PLASTICLIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-023LUXURY ANTISEPTIC (HYDROGEN PEROXIDE) LIQUID [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20210312_056bb861-b758-4c9f-8a0b-6f985c7f4cb7.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-02376772-023-17

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
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bd3aecf5-3815-53d6-e053-2a95a90a83db056bb861-b758-4c9f-8a0b-6f985c7f4cb72021-03-10WarningsExact identifier
spl id: bd3aecf5-3815-53d6-e053-2a95a90a83db
spl set id: 056bb861-b758-4c9f-8a0b-6f985c7f4cb7

Reported adverse events (FAERS/openFDA)#

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