SOFTENSURE FOAM ANTIMICROBIAL- chloroxylenol liquid

SoftenSure Foam Antimicrobial by

Drug Labeling and Warnings

SoftenSure Foam Antimicrobial by is a Otc medication manufactured, distributed, or labeled by Best Sanitizers, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol 1.0%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

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
  

WARNINGS

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.

DOSAGE & ADMINISTRATION

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)
  

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions?

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

PRINCIPAL DISPLAY PANEL

versaclenz compatible

SoftenSure

foam soap

antimicrobial

BEST

SANITIZERS

INC.

Net Contents:

INGREDIENTS AND APPEARANCE

SOFTENSURE FOAM ANTIMICROBIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59900-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59900-127-05	1250 mL in 1 BOX; Type 0: Not a Combination Product	05/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2019

Labeler - Best Sanitizers, Inc. (957473614)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc.		627278224	manufacture(59900-127)