FORTICEPT ANTIMICROBIAL GEL- benzethonium chloride gel

Forticept Antimicrobial Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient/Purpose

Benzethonium Chloride............Antiseptic

Thymol................................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 ForticeptTM 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:

Allantoin, Blue #1 dye, Cetearyl Alcohol, Chamomile (Matricaria recutita) Extract, Glycerin, Lanolin, Mineral oil, Petrolatum, Polyhexanide, Shea Butter, Simulgel EG, Steareth-2, Steareth-21, Water, Yarrow (Achillea millefolium) Extract

60g PLPLDP

90g PLPLDP

120g PLPLDP

INGREDIENTS AND APPEARANCE

FORTICEPT ANTIMICROBIAL GEL 
benzethonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-0701
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
allantoin (UNII: 344S277G0Z)	2 g  in 1000 g
fd&c blue no. 1 (UNII: H3R47K3TBD)	0.009 g  in 1000 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	2.8 g  in 1000 g
chamomile (UNII: FGL3685T2X)	.1 g  in 1000 g
glycerin (UNII: PDC6A3C0OX)	20 g  in 1000 g
isohexadecane (UNII: 918X1OUF1E)	3 g  in 1000 g
LANOLIN (UNII: 7EV65EAW6H)	1.2 g  in 1000 g
mineral oil (UNII: T5L8T28FGP)	1.6 g  in 1000 g
petrolatum (UNII: 4T6H12BN9U)	3.6 g  in 1000 g
polihexanide (UNII: 322U039GMF)	2 g  in 1000 g
polysorbate 80 (UNII: 6OZP39ZG8H)	0.5 g  in 1000 g
shea butter (UNII: K49155WL9Y)	.8 g  in 1000 g
sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 MW) (UNII: 1DXE3F3OZX)	6.5 g  in 1000 g
STEARETH-2 (UNII: V56DFE46J5)	1.2 g  in 1000 g
STEARETH-21 (UNII: 53J3F32P58)	1.2 g  in 1000 g
water (UNII: 059QF0KO0R)	951.591 g  in 1000 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)	.1 g  in 1000 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-0701-0	60 g in 1 TUBE; Type 0: Not a Combination Product	10/27/2016
2	NDC: 52261-0701-1	90 g in 1 TUBE; Type 0: Not a Combination Product	10/27/2016
3	NDC: 52261-0701-2	120 g in 1 TUBE; Type 0: Not a Combination Product	10/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/27/2016

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-0701) , label(52261-0701) , pack(52261-0701)