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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Forticept Wounds and Burns Hydrogel

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.

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

When using this product avoid contact with eyes.

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

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.

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:

For Questions:

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

Please call: +1 212 709-8133

3oz label

4oz label

FORTICEPT WOUNDS AND BURNS HYDROGEL 
benzethonium chloride, lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72127-0803
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.001 kg  in 1 kg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72127-0803-00.114 kg in 1 TUBE; Type 0: Not a Combination Product05/06/2020
2NDC:72127-0803-10.085 kg in 1 TUBE; Type 0: Not a Combination Product02/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/06/2020
Labeler - Lidan, inc. (014456716)
Registrant - Lidan, inc. (014456716)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(72127-0803) , api manufacture(72127-0803) , label(72127-0803) , pack(72127-0803)

Revised: 12/2022
Document Id: 1a6ffa10-df5f-417f-b379-e89d63b72026
Set id: c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f
Version: 4
Effective Time: 20221229
 
Lidan, inc.