FORTICEPT ANTIMICROBIAL GEL- benzethonium chloride gel 
Cosco International, 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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Drug Facts

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 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 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

60g PLPLDP

90g PLPLDP

90g PLPLDP

120g PLPLDP

120g PLPLDP

FORTICEPT ANTIMICROBIAL GEL 
benzethonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0701
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0701-060 g in 1 TUBE; Type 0: Not a Combination Product10/27/2016
2NDC:52261-0701-190 g in 1 TUBE; Type 0: Not a Combination Product10/27/2016
3NDC:52261-0701-2120 g in 1 TUBE; Type 0: Not a Combination Product10/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/27/2016
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0701) , label(52261-0701) , pack(52261-0701)

Revised: 10/2016
Document Id: 93d1511d-c343-47be-8261-2632b4dd8dcb
Set id: 9da1bd69-eab6-493b-8f5c-5247f8af237c
Version: 2
Effective Time: 20161027
 
Cosco International, Inc.