FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING- benzethonium chloride, thymol gel

Forticept Antimicrobial Hydrogel Wound Dressing by

Drug Labeling and Warnings

Forticept Antimicrobial Hydrogel Wound Dressing by is a Otc medication manufactured, distributed, or labeled by Lidan, Inc, Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings For external use only.

INDICATIONS & USAGE

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

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

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

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING 
benzethonium chloride, thymol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72127-0901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzethonium chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	benzethonium chloride	1 g  in 1000 g
thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	thymol	1 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72127-0901-1	85 g in 1 TUBE; Type 0: Not a Combination Product	02/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/20/2022

Labeler - Lidan, Inc (014456716)

Registrant - Lidan, Inc (014456716)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(72127-0901) , label(72127-0901) , pack(72127-0901) , api manufacture(72127-0901)