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Forticept Antimicrobial Gel

Dosage form: gel
Ingredients: benzethonium chloride 1g in 1000g, thymol 1g in 1000g
Labeler: Cosco International, Inc.
NDC Code: 52261-0701

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.

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

90g PLPLDP

120g PLPLDP

FORTICEPT ANTIMICROBIAL GEL 
benzethonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzethonium chloride (BENZETHONIUM) benzethonium chloride1 g  in 1000 g
thymol (THYMOL) thymol1 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
allantoin2 g  in 1000 g
fd&c blue no. 10.009 g  in 1000 g
CETOSTEARYL ALCOHOL2.8 g  in 1000 g
chamomile.1 g  in 1000 g
glycerin20 g  in 1000 g
isohexadecane3 g  in 1000 g
LANOLIN1.2 g  in 1000 g
mineral oil1.6 g  in 1000 g
petrolatum3.6 g  in 1000 g
polihexanide2 g  in 1000 g
polysorbate 800.5 g  in 1000 g
shea butter.8 g  in 1000 g
sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 MW)6.5 g  in 1000 g
STEARETH-21.2 g  in 1000 g
STEARETH-211.2 g  in 1000 g
water951.591 g  in 1000 g
ACHILLEA MILLEFOLIUM.1 g  in 1000 g
Packaging
#Item CodePackage Description
1NDC:52261-0701-060 g in 1 TUBE
2NDC:52261-0701-190 g in 1 TUBE
3NDC:52261-0701-2120 g in 1 TUBE
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/FEIOperations
Cosco International, Inc.016433141manufacture(52261-0701), label(52261-0701), pack(52261-0701)

Revised: 10/2016
 
Cosco International, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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