RoyaLab Germ Away Antibacterial: Package Insert and Label Information

ROYALAB GERM AWAY ANTIBACTERIAL- chloroxylenol soap
Royal Papers, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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

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.

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 1 g in 1 L

Inactive Ingredients Ingredient Name Strength PROPANEDIOL PROPYLENE GLYCOL WATER FD&C RED NO. 40 METHYLCHLOROISOTHIAZOLINONE FD&C YELLOW NO. 5 SODIUM LAURETH-3 SULFATE COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE EUGENOL SODIUM CHLORIDE METHYLISOTHIAZOLINONE CINNAMALDEHYDE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82077-701-41 3.78 L in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/30/2021

Labeler — Royal Papers, Inc. (006335392)

Registrant — Midlab (047371463)

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

Revised: 06/2021 Royal Papers, Inc.