DERMA CIDOL 2000- chloroxylenol liquid

Derma CIDOL 2000 by

Drug Labeling and Warnings

Derma CIDOL 2000 by is a Otc medication manufactured, distributed, or labeled by Rosedale Therapeutics, LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

0.5% Chloroxylenol

Purpose

Healthcare Personnel Handwash

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

INGREDIENTS AND APPEARANCE

DERMA CIDOL 2000 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10802-8081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10802-8081-7	355 mL in 1 CONTAINER
2	NDC: 10802-8081-9	3790 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/18/2015

Labeler - Rosedale Therapeutics, LLC (161264622)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	manufacture(10802-8081)