ULTRA- chloroxylenol 0.3% liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Available from:
Kroger Co
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial  for handwashing to decrease bacteria on the skin - irritation or redness develops - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
30142-562-50

ULTRA- chloroxylenol 0.3% liquid

Kroger Co

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.

----------

drug facts

claims

Kroger

home

sense

Active ingredient

Chloroxylenol 0.3%

Purpos e

Antibacterial

Us e

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,

alcohol denatured, phenoxyethanol, sodium chloride, sodium xylenesulfonate, citric acid,

methylisothiazolinone, fragrance, yellow 5

questions or comments?

1-800-632-6900

Warnings and claims

WARNING Not for use in dishwasher. Do not add bleach.

Phosphate Free. Contains Biodegradable Surfactants.

Dis lcaimer

DAWN ULTRA CONCENTRATED DISHWASHING LIQUID IS A REGISTERED TRADEMARK

OF PROCTER & GAMBLE, CINCINNATI, OHIO 45202. PROCTER & GAMBLE IS NOT

AFFILATED WITH THE KROGER CO. OR THIS PRODUCT

ADVERSE REACTIONS

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

562.000/AA

principal display panel

Compare to DAWN Ultra Concentrated

Dishwashing Liquid

*see back panel

Kroger

home sense

Ultra Liquid

Dish Soap

And Antibacterial Hand Soap

Tough on Grease

Citrus Scent

24 FL OZ (709 mL)

ULTRA

chloroxylenol 0.3% liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-56 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78 V2Q)

CHLOROXYLENOL

3.0 9 g in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

wa ter (UNII: 0 59 QF0 KO0 R)

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

LAURAMINE O XIDE (UNII: 4F6 FC4MI8 W)

Kroger Co

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:30 142-56 2-

70 9 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/29 /20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 4/29 /20 15

Labeler -

Kroger Co (006999528)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

0 8 8 520 6 6 8

ma nufa c ture (30 142-56 2)

Revised: 4/2019

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