Bright Solutions Antibacterial: Package Insert and Label Information

BRIGHT SOLUTIONS ANTIBACTERIAL- chloroxylenol soap
MIDLAB INCORPORATED

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.

Active Ingredient

PCMX 0.1%.

Purpose

Antiseptic Handwashing

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.

Stop use and 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.

BRIGHT SOLUTIONS ANTIBACTERIAL pcmx, hand soap soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70542-710 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 CINNAMALDEHYDE SODIUM LAURETH-3 SULFATE WATER PROPANEDIOL PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE FD&C YELLOW NO. 5 SODIUM LAURYL SULFATE FD&C RED NO. 40 SODIUM CHLORIDE EUGENOL METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70542-710-41 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 12/31/2020

Labeler — MIDLAB INCORPORATED (047371463)

Registrant — MIDLAB INCORPORATED (047371463)

Establishment
Name	Address	ID/FEI	Operations
MIDLAB INCORPORATED		047371463	manufacture (70542-710)

Revised: 06/2021 MIDLAB INCORPORATED