DERMACEN ANTIMICROBIAL-P HAND- chloroxylenol liquid

DermaCen Antimicrobial-P Hand by

Drug Labeling and Warnings

DermaCen Antimicrobial-P Hand by is a Otc medication manufactured, distributed, or labeled by Central Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Chloroxylenol (PCMX) 0.95%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

An effective antimicrobial hand cleanser

Kills and inhibits bacterial growth on hands

Gentle cleansers leave hands clean and moisturized

Reduces the possibility of cross contamination

WARNINGS

Warnings

For External Use Only

When using this product

Avoid contact with eyes

Discontinue use if irritation occurs

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Use as you would any liquid hand soap.

Wet hands with water, then apply a small amount of product to palm.

Rub hands together vigorously for at least 15 seconds.

Rinse and dry thoroughly.

INACTIVE INGREDIENT

Inactive Ingredients

Purified Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Lauramide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Disodium EDTA, DMDM Hydantoin and Iodopropynyl Butylcarbamate, Sodium Hydroxide, Fragrance, Glycereth-26, Aloe Barbadensis Leaf Juice, Yellow 5, Blue 1

PRINCIPAL DISPLAY PANEL

DermaCen

Antimicrobial-P

Hand Soap

An antimicrobial lotionized

hand soap containing Aloe Vera

to decrease bacteria on the skin

NET CONTENTS 8.5 ounces (251 mL)

INGREDIENTS AND APPEARANCE

DERMACEN ANTIMICROBIAL-P HAND  
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.95 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERETH-26 (UNII: NNE56F2N14)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-231-14	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
2	NDC: 62654-231-37	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
3	NDC: 62654-231-92	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018
4	NDC: 62654-231-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2001

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-231)