Forticept Antimicrobial Gel (Benzethonium Chloride) Gel [Cosco International, Inc.] -

FORTICEPT ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE) GEL [COSCO INTERNATIONAL, INC.]
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NDC	52261-0701-0, 52261-0701-1, 52261-0701-2
Set ID	9da1bd69-eab6-493b-8f5c-5247f8af237c
Category	HUMAN OTC DRUG LABEL
Packager	Cosco International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/27/2016

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

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

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Medic

FORTICEPT ANTIMICROBIAL GEL (BENZETHONIUM CHLORIDE) GEL [COSCO INTERNATIONAL, INC.]

Uses

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