SOFTENSURE FOAM ANTIMICROBIAL- chloroxylenol liquid

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

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Active ingredient:
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Available from:
Best Sanitizers, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses - handwash to help reduce bacteria that potentially can cause disease - helps to prevent cross-contamination by hand contact - helps to prevent drying of the skin - recommended for repeated use
Authorization status:
OTC monograph not final
Authorization number:
59900-127-05

SOFTENSURE FOAM ANTIMICROBIAL- chloroxylenol liquid

Best Sanitizers, 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.

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Drug Facts

Active ingredient

Chloroxylenol 1.0%

Purpos e

Antiseptic

Us es

handwash to help reduce bacteria that potentially can cause disease

helps to prevent cross-contamination by hand contact

helps to prevent drying of the skin

recommended for repeated use

Warnings

For external use only

When using this product

do not use in or near eyes

Stop use and ask a doctor if irritation and redness develop.

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions

wet hands and wrists with clean, running water

apply appropriate amount of product

lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds

rinse thoroughly with running water

dry hands completely (incomplete drying may result in chapped skin)

Other information

store in a cool, dry place below 104 F (40 C)

Inactive ingredients

Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

Ques tions ?

Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

versaclenz compatible

SoftenSure

foam soap

antimicrobial

BEST

SANITIZERS

INC.

Net Contents:

SOFTENSURE FOAM ANTIMICROBIAL

chloroxylenol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 9 0 0 -127

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

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PO TASSIUM CO CO ATE (UNII: F8 U72V8 ZXP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

Best Sanitizers, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 9 0 0 -127-0 5

1250 mL in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 5/15/20 19

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 5/15/20 19

Labeler -

Best Sanitizers, Inc. (957473614)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Best Sanitizers, Inc.

6 27278 224

ma nufa c ture (59 9 0 0 -127)

Revised: 5/2019

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