DERMA CIDOL 2000- chloroxylenol liquid 
Rosedale Therapeutics, LLC

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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Derma CIDOL 2000

Active Ingredient:

0.5% Chloroxylenol

Purpose

Healthcare Personnel Handwash

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Use decreases the level of transient microorganisms on the skin before contact with patients under medical care or treatment.

Warning For external use only

Stop use and ask a doctor if irritation and redness develop and persist for more than 5 days.

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Directions: Wet hands with water and add a small amount of Derma Cidol 2000. Vigorously rub together all surfaces of lathered hands for at least 10 seconds. Thoroughly rinse under a stream of water. Repeat as necessary between patients.

For Professional Use Only

Inactive Ingredients: Cocamidopropyl Betaine, Cocoline Brown, Diazolidinyl urea, Disodium EDTA, Disodium Laureth Sulfosuccinate, FD&C Red 40, Fragrance, PEG-150, Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Triglycerides, Polysorbate 20, Propylene Glycol, Purified Water USP, Sodium Laureth Sulfate, Sodium Lauryl Sulfoacetate

Packaging

Derma Cidol

DERMA CIDOL 2000 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10802-8081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PENTAERYTHRITYL TETRASTEARATE (UNII: W9Q3DZS0EG)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10802-8081-7355 mL in 1 CONTAINER
2NDC:10802-8081-93790 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/18/2015
Labeler - Rosedale Therapeutics, LLC (161264622)
Establishment
NameAddressID/FEIBusiness Operations
Ei LLC105803274manufacture(10802-8081)

Revised: 2/2015
Document Id: 6f145cf1-e5d4-4f73-b40e-b7e6ef78456c
Set id: 4370f140-0403-4501-8016-86dd759385c4
Version: 1
Effective Time: 20150218
 
Rosedale Therapeutics, LLC