ULTRA- chloroxylenol 0.3% liquid

Ultra by

Drug Labeling and Warnings

Ultra by is a Otc medication manufactured, distributed, or labeled by Old East Main Co, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.3%

Purpose

Antibacterial

Use

 for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

• do not get into eyes.  If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation or redness develops
• condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• wet hands
• apply palmful to hands
• scrub thoroughly
• rinse thoroughly

Inactive ingredients

water, sodium C14-16 olefin sulfonate, lauramine oxide, sodium laureth sulfate, sodium lauryl sulfate, sodium xylenesulfonate, sodium chloride, alcohol denat., fragrance, phenoxyethanol, citric acid, methylisothiazolinone, yellow 5, blue 1

SPL UNCLASSIFIED SECTION

WARNING

NOT FOR USE IN DISHWASHERS.

DO NOT ADD BLEACH

Phosphate Free Contains Surfactamts

When compared to non-concentrated formulas

This product is not manufactured or distributed by Procter & Gamble,

distributor of Dawn Ultra Antibacterial Hand Soap Apple Blossom

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

ULTRA CONCENTRATED 2X CLEANING POWER

DG home

Ultra Antibacterial Hand Soap

Dishwashing Liquid

TOUGH ON GREASE

Compare to Dawn Ultra

Antibacterial Hand Soap

Apple Blossom Scent

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

ULTRA 
chloroxylenol 0.3% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-589
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.09 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-589-44	709 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/17/2017

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(55910-589)