SKYLINE ANTIBACTERIAL HAND CLEANSER- parachlorometaxylenol liquid

Skyline Antibacterial Hand Cleanser by

Drug Labeling and Warnings

Skyline Antibacterial Hand Cleanser by is a Otc medication manufactured, distributed, or labeled by Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient

Parachlorometaxylenol 0.3%

PURPOSE

Purpose

Antibacterial

DOSAGE & ADMINISTRATION

Uses

• For hand washing to decrease bacterial on the skin.

WARNINGS

Warnings

For external use only.

When using this product

• Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Pump into hands, wet as needed.
• Lather vigorously for at lease 15 seconds
• Wash Skin, rinse thoroughly and dry

INACTIVE INGREDIENT

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerine, Aloe Vera, Sodium Chloride, DMDM hydantion, Fragrance, FD&C Blue # 1

SPL UNCLASSIFIED SECTION

Manufactured by:

Morgan-Gallacher, Inc.

8707 Millergrove Drive

Santa Fe Springs, CA 90670

(562) 695 -1232

INGREDIENTS AND APPEARANCE

SKYLINE ANTIBACTERIAL HAND CLEANSER 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	chloroxylenol	0.30 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50241-141-01	3.79 kg in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2014

Labeler - Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. (028311595)

Registrant - Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. (028311595)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc.		028311595	manufacture(50241-141)