floraseptic wound gel - antimicrobial skin & wound hydrogel

floraseptic wound gel - antimicrobial skin & wound hydrogel
SPL v2
SPL
SPL Set ID 2fdb5327-76b5-4886-836b-2351d4bcc7be
Route
topical
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzethonium (0.0012 kg) allantoin (0.0050 kg)
Inactive Ingredients
aloe vera leaf hydrolysed bovine collagen (enzymatic; 2000-5000 mw) c13-14 isoparaffin alcohol ethylhexylglycerin glycerin hydrastis canadensis whole laureth-7 panax quinquefolius whole phenoxyethanol sodium acryloyldimethyltaurate-acrylamide copolymer (1:1; 90000-150000 mpa.s) hyaluronate sodium sodium hydroxide water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-30

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

Description

Active Ingredient/Purpose: Benzethonium Chloride (0.12%)..............Antiseptic Allantoin (0.5%)...............................Skin Protectant


Medication Information

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

Description

Active Ingredient/Purpose: Benzethonium Chloride (0.12%)..............Antiseptic Allantoin (0.5%)...............................Skin Protectant

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

Section 50565-1

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51945-4

Warnings:

For external use only.

Drug Facts

Active Ingredient/Purpose:

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

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

Directions:

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

Do Not Use:

• in the eyes

• over large areas of the body

For Questions:

+1-(833) 432-5435

BonePharm, LLC.

6104 River Terrace

Tampa, FL  33604

1 (833) HEALGEL

WWWBONEPHARM.COM

Inactive Ingredients:

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:

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

When Using This Product:

• 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:

• Condition worsens

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

Ask A Doctor Before Use If You Have:

• deep or puncture wounds

• deep cuts

• animal bites

• serious burns


Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51945-4 (51945-4)

Warnings:

For external use only.

Drug Facts (DRUG FACTS)

Active Ingredient/Purpose:

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

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

Directions:

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

Do Not Use: (Do not use:)

• in the eyes

• over large areas of the body

For Questions:

+1-(833) 432-5435

BonePharm, LLC.

6104 River Terrace

Tampa, FL  33604

1 (833) HEALGEL

WWWBONEPHARM.COM

Inactive Ingredients:

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: (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

When Using This Product: (When using this product:)

• 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: (Stop use and ask a doctor if:)

• Condition worsens

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

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

• deep or puncture wounds

• deep cuts

• animal bites

• serious burns


Advanced Ingredient Data


Raw Label Data

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