Baclezene

Manufacturer
Curazene, LLC | Ultra Seal Corp.
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:09:35

Label at a glance#

ProductBaclezene
Active ingredientNEOMYCIN SULFATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: (in each 0.9 gram) : Neomycin Sulfate, 5mg

INDICATIONS & USAGE SECTION

Uses: First aid to prevent infection in minor cuts, scrapes, burns

OTC - PURPOSE SECTION

Purpose: First Aid Antibiotic

WARNINGS SECTION

Warnings: For external use only.  Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body.  Ask a doctor before use if you have: large puncture wounds, animal bites, serious burns. 

Stop use and ask a doctor if: you need to use longer than one week, condition persists or gets worse, symptoms persist for more than one week or clear up and occur again within a few days, rash or other allergic reaction develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years of age or older: Clean the affected area.  Apply contents of packet to surface of affected area 2 times daily.  Gently rub in. Children under 2 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Ascorbic Acid, Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin, Glycerol MS S.E., Magnesium Stearate, Methyl Paraben, Phenoxyethanol, Polysorbate 80, SDBS, Trisodium Citrate, Stearic Acid, USP Water, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baclezene CartonBaclezene Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52599-282-832023-01-03C16284748780-19d75b9d0-16db-f424-e053-dadaa90a57ceDrug Facts
52599-282-832020-01-31C16284748780-19d75b9d0-16db-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266933
NEOMYCINACTIVE MOIETYI16QD7X2973
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52599-28252599-282-82, 52599-282-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 478 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
78 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates

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
f1606841-0a29-151b-e053-2a95a90a2813a82852eb-18e9-431a-b3d6-80abfdbf86622023-01-03WarningsExact identifier
spl set id: a82852eb-18e9-431a-b3d6-80abfdbf8662

Reported adverse events (FAERS/openFDA)#

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