Forticept Wounds And Burns Hydrogel

Forticept Wounds And Burns Hydrogel
SPL v5
SPL
SPL Set ID c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f
Route
TOPICAL
Published
Effective Date 2022-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.001 kg) Lidocaine (0.04 kg)
Inactive Ingredients
Allantoin .alpha.-tocopherol Acetate, Dl- C13-14 Isoparaffin Cetostearyl Alcohol Chlorphenesin Dexpanthenol Fd&c Blue No. 1 Glycerin Hydrolysed Bovine Collagen (enzymatic; 2000-5000 Mw) Lanolin Laureth-7 Mineral Oil Petrolatum Polyacrylamide (10000 Mw) Polihexanide Shea Butter Steareth-2 Steareth-21 Thymol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-06

Description

Active Ingredient/Purpose: LIDOCAINE HCL (4.0%)..........................Topical Analgesic BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Storage and Handling

Keep container closed when not in use. Store at room temperature, avoid freezing. Do not store below 32F/0 0 C or above 95F/35 0 C for extended periods of time.


Medication Information

Indications and Usage

Topical analgesic - for temporary relief of pain or discomfort for superficial and full thickness burns or wounds.

Topical antiseptic - to help decrease the risk of wounf and skin infections.

Storage and Handling

Keep container closed when not in use. Store at room temperature, avoid freezing. Do not store below 32F/0 0 C or above 95F/35 0 C for extended periods of time.

Description

Active Ingredient/Purpose: LIDOCAINE HCL (4.0%)..........................Topical Analgesic BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Uses:

For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

Section 50565-1

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

Section 50566-9

Discontinue Use after 7 days unless directed by a doctor

Section 50567-7

When using this product avoid contact with eyes.

Section 50569-3

For children under 2 years of age: please, consult a doctor

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 51945-4

Warnings:

For external use only!

Drug Facts

Active Ingredient/Purpose:

LIDOCAINE HCL (4.0%)..........................Topical Analgesic

BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Directions:

Adults and children 2 years of age and older:

• Clean affected area from dirt and debris, let it dry.

• Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed.

• Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

For Questions:

Lidan, Inc.

30 Wall Street, 8th Floor

New York, NY 10005

www.forticept.com

Please call: +1 212 709-8133

Inactive Ingredients:

ALLANTOIN, ALPHA TOCOPHEROL, C13-14 ISOPARAFFIN, CETOSTEARYL ALCOHOL, CHLORPHENESIN, D-PANTHENOL, FD&C BLUE #1, GLYCERIN, HYDROLYZED COLLAGEN, LANOLIN, LAURETH-7, PARAFFINUM LIQUIDUM, PETROLATUM, POLYACRYLAMIDE, POLYHEXANIDE, SHEA BUTTER, STEARETH-2, STEARETH-21, THYMOL, WATER

Storage and Handling:
  • Keep container closed when not in use.
  • Store at room temperature, avoid freezing.
  • Do not store below 32F/00C or above 95F/350C for extended periods of time.

Structured Label Content

Uses:

For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

Indications and Usage (34067-9)

Topical analgesic - for temporary relief of pain or discomfort for superficial and full thickness burns or wounds.

Topical antiseptic - to help decrease the risk of wounf and skin infections.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Discontinue Use after 7 days unless directed by a doctor

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 50569-3 (50569-3)

For children under 2 years of age: please, consult a doctor

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 51945-4 (51945-4)

Warnings: (WARNINGS:)

For external use only!

Drug Facts (DRUG FACTS)

Active Ingredient/Purpose:

LIDOCAINE HCL (4.0%)..........................Topical Analgesic

BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Directions:

Adults and children 2 years of age and older:

• Clean affected area from dirt and debris, let it dry.

• Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed.

• Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

For Questions:

Lidan, Inc.

30 Wall Street, 8th Floor

New York, NY 10005

www.forticept.com

Please call: +1 212 709-8133

Inactive Ingredients:

ALLANTOIN, ALPHA TOCOPHEROL, C13-14 ISOPARAFFIN, CETOSTEARYL ALCOHOL, CHLORPHENESIN, D-PANTHENOL, FD&C BLUE #1, GLYCERIN, HYDROLYZED COLLAGEN, LANOLIN, LAURETH-7, PARAFFINUM LIQUIDUM, PETROLATUM, POLYACRYLAMIDE, POLYHEXANIDE, SHEA BUTTER, STEARETH-2, STEARETH-21, THYMOL, WATER

Storage and Handling: (Storage and handling:)
  • Keep container closed when not in use.
  • Store at room temperature, avoid freezing.
  • Do not store below 32F/00C or above 95F/350C for extended periods of time.

Advanced Ingredient Data


Raw Label Data

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