FloraSeptic Wound Gel

Manufacturer
Cosco International, Inc.
Effective date
2022-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:02

Label at a glance#

ProductFloraSeptic Wound Gel
Active ingredientBENZETHONIUM CHLORIDE, ALLANTOIN
Label structure13 sections

Indications and uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin, and lips. Topical antiseptic to help decrease the risk of infection

Dosage and administration

Adults and children 2 years of age and older: • Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or a wound cleanser and let air dry • Apply appropriate layer of the gel to cover the affected area • Cover with adhesive bandage or sterile gauze if needed • Apply 1 to 3 times daily • Children under 2 years of age: ask a doctor

Storage and handling

Store at room temperature 68°F to 77°F (20° to 25°C) Do not expose to excessive heat May discolor or stain certain fabrics

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient/Purpose:

Benzethonium Chloride (0.12%)..............Antiseptic

Allantoin (0.5%)...............................Skin Protectant

Uses:

OTC - PURPOSE SECTION

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin, and lips. Topical antiseptic to help decrease the risk of infection

Warnings:

WARNINGS SECTION

For external use only.

Do not use:

Indications & Usage Section

• in the eyes
• over large areas of the body

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

• deep or puncture wounds
• deep cuts
• animal bites
• serious burns

When using this product:

OTC - WHEN USING SECTION

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Apply only to the affected area. Avoid ingestion.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

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 immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:
• Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or a wound cleanser and let air dry
• Apply appropriate layer of the gel to cover the affected area
• Cover with adhesive bandage or sterile gauze if needed
• Apply 1 to 3 times daily
• Children under 2 years of age: ask a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, C13-14 Isoparaffin, Ethanol, Ethylhexylglycerin, Glycerin, Hydrastis Canadensis L., Hydrolyzed Bovine Collagen, Laureth-7, Panax Quinquefolius L., Phenoxyethanol, Sodium Acryloyldimethyltaurate-Acrylamide Copolymer, Sodium Hyaluronate, Sodium Hydroxide, Water

Storage and handling:

SPL UNCLASSIFIED SECTION

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat
May discolor or stain certain fabrics

For Questions:

OTC - QUESTIONS SECTION

+1-(833) 432-5435
BonePharm, LLC.

6104 River Terrace
Tampa, FL  33604

1 (833) HEALGEL
WWWBONEPHARM.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3oz tube label3oz tube label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0602-12025-01-30C16284748780-12cef2736-ac92-d83d-e063-dadaa90ab31fFloraSeptic Wound Gel - Antimicrobial Skin & Wound Hydrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0602-1FloraSeptic Wound Gel0.0850 kg in 1 TUBEGEL0.08501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0602FLORASEPTIC WOUND GEL (BENZETHONIUM CHLORIDE, ALLANTOIN) GEL [COSCO INTERNATIONAL, INC.]1Legacy NDC, 1 package rows20220702_ca9dc12e-96b9-470d-9b5f-35ea652b3349.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-060252261-0602-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
690c76d2-9577-4b2b-a933-464c42a5bb2bca9dc12e-96b9-470d-9b5f-35ea652b33492022-06-30WarningsExact identifier
spl id: 690c76d2-9577-4b2b-a933-464c42a5bb2b
spl set id: ca9dc12e-96b9-470d-9b5f-35ea652b3349

Reported adverse events (FAERS/openFDA)#

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