SOFTENSURE ANTIMICROBIAL FOAM- benzalkonium chloride liquid

SoftenSure Antimicrobial Foam by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.12%

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 amount 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

Water, cocamidopropyl betaine, glycerine, polyethylene-polypropylene glycol, benzyl alcohol, phenoxyethanol, tetrasodium EDTA, dehydroacetic acid, sodium hydroxide, citric acid

Questions?

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

PRINCIPAL DISPLAY PANEL

foam

soap

Soften

Sure

ANTIMICROBIAL

FOAM SOAP

Benzalkonium Chloride

Fragrance and Dye Free

For Professional Use

NSF

Nonfood Compounds

Program Listed (E2)

Registration #166522

KC

PAREVE

Net Contents: 500mL (16.9 FL OZ)

INGREDIENTS AND APPEARANCE

SOFTENSURE ANTIMICROBIAL FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59900-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM EDTA (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLOXAMER 124 (UNII: 1S66E28KXA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59900-216-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2023
2	NDC: 59900-216-02	12 in 1 CASE	12/26/2023
2		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59900-216-03	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2023
4	NDC: 59900-216-04	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(59900-216)