FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING- benzethonium chloride, thymol 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 Antimicrobial Hydrogel Wound Dressing

Active Ingredient/Purpose

Benzethonium Chloride - 0.1%............Antiseptic

Thymol - 0.1%..................................Antiseptic

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 skin infections.

Warnings For external use only.

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

When using this product avoid contact with eyes.

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.

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

Directions:

Adults and children 2 years of age and older:

Clean affected area from dirt and debris, let it dry. Apply a thin layer of Forticept Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.

Children under 2 years of age: please, consult a doctor

Storage and handling:

Store at room temperature, avoid freezing

Inactive ingredients:

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Alpha Tocopherol, Cetostearyl Alcohol, Panthenol, Glycerin, Hydrolyzed Collagen, Isohexadecane, Lanolin, Mineral Oil, Petrolatum, Polihexanide, Polysorbate 80, Shea Butter, Steareth-2, Steareth-21, Water

85g Tube

85g Tube

FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING 
benzethonium chloride, thymol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72127-0901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzethonium chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) benzethonium chloride1 g  in 1000 g
thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) thymol1 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLIHEXANIDE (UNII: 322U039GMF)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72127-0901-185 g in 1 TUBE; Type 0: Not a Combination Product02/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/20/2022
Labeler - Lidan, Inc (014456716)
Registrant - Lidan, Inc (014456716)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(72127-0901) , label(72127-0901) , pack(72127-0901) , api manufacture(72127-0901)

Revised: 2/2022
Document Id: 6af707c4-f5c8-4d3c-8ddf-ddc9ce494dd6
Set id: cd5b7a72-1b87-434d-973e-071d2c8a438c
Version: 1
Effective Time: 20220220
 
Lidan, Inc