FORTICEPT WOUNDS AND BURNS HYDROGEL- benzethonium chloride, lidocaine hydrochloride gel

Forticept Wounds and Burns Hydrogel by

Drug Labeling and Warnings

Forticept Wounds and Burns Hydrogel by is a Otc medication manufactured, distributed, or labeled by Lidan, inc., Cosco International, Inc., Pharmex Group, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

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.

INDICATIONS & 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.

WARNINGS:

For external use only!

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

When using this product avoid contact with eyes.

DO NOT USE

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

STOP USE

Discontinue Use after 7 days unless directed by a doctor

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.

ASK DOCTOR

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

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.

For Questions:

Lidan, Inc.
30 Wall Street, 8th Floor
New York, NY 10005
www.forticept.com

Please call: +1 212 709-8133

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTICEPT WOUNDS AND BURNS HYDROGEL 
benzethonium chloride, lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72127-0803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.001 kg  in 1 kg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)
LANOLIN (UNII: 7EV65EAW6H)
LAURETH-7 (UNII: Z95S6G8201)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLIHEXANIDE (UNII: 322U039GMF)
SHEA BUTTER (UNII: K49155WL9Y)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72127-0803-0	0.114 kg in 1 TUBE; Type 0: Not a Combination Product	05/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/06/2020

Labeler - Lidan, inc. (014456716)

Registrant - Lidan, inc. (014456716)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(72127-0803) , relabel(72127-0803) , pack(72127-0803)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmex Group, LLC.		365309015	manufacture(72127-0803) , relabel(72127-0803) , pack(72127-0803) , repack(72127-0803)