OTC Medication Information: Ultra

ULTRA- chloroxylenol liquid
Old East Main Co

Disclaimer

Do not add bleach.

Not for use in dishwasher.

Contains Surfactants

*This product is not manufactured or distributed by Proctor & Gamble, distributor of Dawn®  Ultra Antibacterial Hand Soap Apple Blossom®  Scent.

**when compared to non-concentrated formulas

Adverse reaction

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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 or lauramidopropylamine oxide and myristamidopropylamine oxide, sodium laureth sulfate, sodium chloride, sodium lauryl sulfate, sodium xylenesulfonate, alcohol denat., fragrance, citric acid, methylisothiazolinone, tetrasodium EDTA, yellow 5, blue 1

Adverse reaction

DISTRIBUTED BY OLD EAT MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal display panel

ULTRA CONCENTRATED 3X CLEANING POWER**

truekiving

Ultra Antibacterial Hand Soap

Dishwashing Liquid

TOUGH ON GREASE

Compare to Dawn Ultra Antibacterial Hand Soap Apple Blossom Scent*

CRISP GREEN APPLE

image description
(click image for full-size original)
ULTRA
chloroxylenol 0.3% liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-589
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
SODIUM C14-16 OLEFIN SULFONATE
LAURAMINE OXIDE
LAURAMIDOPROPYLAMINE OXIDE
MYRISTAMIDOPROPYLAMINE OXIDE
SODIUM LAURETH SULFATE
SODIUM CHLORIDE
SODIUM LAURYL SULFATE
SODIUM XYLENESULFONATE
ALCOHOL
CITRIC ACID MONOHYDRATE
METHYLISOTHIAZOLINONE
EDETATE SODIUM
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-589-44 532 mL in 1 BOTTLE, DISPENSING None
2 NDC:55910-589-57 1183 mL in 1 BOTTLE, DISPENSING None
3 NDC:55910-589-68 1656 mL in 1 BOTTLE, DISPENSING None
4 NDC:55910-589-38 1124 mL in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M505G(a)(3) 01/17/2017
Labeler — Old East Main Co (068331990)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (55910-589)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (55910-589)

Revised: 12/2023 Old East Main Co

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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