SOFTENSURE ANTIMICROBIAL LIQUID- chloroxylenol liquid

SoftenSure Antimicrobial Liquid by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.75%

Purpose

Antiseptic Hand Cleanser

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

For external use only

When using this product do not use in or near eyes.

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

Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

Directions

wet hands and wrists with potable water

apply appropriate amounts of product

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

rinse thoroughly with potable water before handling food

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

Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No. 8, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

Questions?

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

PRINCIPAL DISPLAY PANEL

liquid

soap

Soften

Sure

ANTIMICROBIAL

LIQUID SOAP

Chloroxylenol (PCMX)

Light Fragrance

For Frequent Use

Net Contents: 16.9 FL OZ (500mL)

INGREDIENTS AND APPEARANCE

SOFTENSURE ANTIMICROBIAL LIQUID 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59900-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.75 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDE MEA (UNII: C80684146D)
COCO-BETAINE (UNII: 03DH2IZ3FY)
COCONUT ACID (UNII: 40U37V505D)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
2-AMINOETHANOL (UNII: 5KV86114PT)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C GREEN NO. 8 (UNII: I2W85YOX9L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
OLEIC ACID (UNII: 2UMI9U37CP)
SODIUM SULFATE (UNII: 0YPR65R21J)
TETRASODIUM EDTA (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59900-217-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2023
2	NDC: 59900-217-02	12 in 1 CASE	12/26/2023
2		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59900-217-03	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2023
4	NDC: 59900-217-04	4 in 1 CASE	12/26/2023
4		1200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/26/2023

Labeler - Best Sanitizers, Inc (957473614)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc		627278224	manufacture(59900-217)