SOFTEN SURE 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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Soften Sure Foam Soap

Active Ingredient

Chloroxylenol 1.0%

Purpose

Antimicrobial Hand Cleanser

Uses

Handwash to help reduce bacteria that potentially can cause diseases
Helps to prevent cross contaminiation 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.

Keep out of reach of children

In case of accidental ingestion seek medical attention or contact a poison center immediately.

Directions

Wet hands and forearms
Apply an application to hands and forearms
Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
Rinse

Other Information

Store in a cool dry place below 104° F

Inactive ingredients

purified water, potassium cocoate, tetrasodium EDTA, FDC No. 1, Yellow No.5, fragrance

Questions?

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

NDC 59900-211-06

NDC 59900-211-10

NDC 59900-211-11

Soften Sure Foam Soap antimicrobial

Principal Display Panel

SOFTEN SURE FOAM ANTIMICROBIAL
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59900-211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	10 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59900-211-06	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2008
2	NDC:59900-211-10	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2008
3	NDC:59900-211-11	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/01/2008

Labeler - Best Sanitizers, Inc (957473614)

Name	Address	ID/FEI	Business Operations
Establishment
Best Sanitizers, Inc		627278224	manufacture(59900-211)