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

Chloroxylenol 0.1%.

Purpose

Antiseptic

Uses

Handwash to help decrease bacteria on the skin.

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 of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Fragrance (Proprietary), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), Dibromocyanoacetamide (10222-01-2), Yellow 5 (1934-21-0), Red 40 (25956-17-6).

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
BRONOPOL (UNII: 6PU1E16C9W)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
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)
EUGENOL (UNII: 3T8H1794QW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED) (UNII: G7SW5QN7TT)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DIBROMOCYANOACETAMIDE (UNII: 7N51QGL6MJ)

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)