ROYALAB GERM AWAY ANTIBACTERIAL- pmcx, handwashing and hand soap soap

RoyaLab Germ Away Antibacterial by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

PCMX 0.1%.

Purpose

Antiseptic Handwashing

Uses

Dishwashing concentrate and antimicrobial hand soap.

Warnings

For external use only.
Do not use in the eyes. In case of contact, immediately flush eyes with water.

ASK DOCTOR

Stop use and ask a doctor if irritation or rash appears and lasts.

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.

Directions

Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate, Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, and Red 40.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYALAB GERM AWAY ANTIBACTERIAL 
pmcx, handwashing and hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82077-701
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EUGENOL (UNII: 3T8H1794QW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CINNAMALDEHYDE (UNII: SR60A3XG0F)

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: 82077-701-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/30/2021

Labeler - Royal Papers, Inc. (006335392)

Registrant - Midlab (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
Midlab, Inc.		047371463	manufacture(82077-701)