ROYALAB GERM AWAY- pcmx, dishwashing and hand soap soap

RoyaLab Germ Away by

Drug Labeling and Warnings

RoyaLab Germ Away by is a Otc medication manufactured, distributed, or labeled by Midlab Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYALAB GERM AWAY 
pcmx, dishwashing and hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.1 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70542-703-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/12/2017

Labeler - Midlab Incorporated (047371463)

Registrant - Midlab Incorporated (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
Midlab Incorporated		047371463	manufacture(70542-703)