SOFTCIDE- chloroxylenol soap

SOFTCIDE by

Drug Labeling and Warnings

SOFTCIDE by is a Otc medication manufactured, distributed, or labeled by Erie Scientific LLC, KUTOL PRODUCTS COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CHLOROXYLENOL............1%

PURPOSE

ANTICEPTIVE AGENT

INDICATIONS & USAGE

Handwash to help reduce bacteria that can potentially cause disease. Reduces the risk and chance of cross -infection.

WARNINGS

For external use only.

If swallowed seek medical help or contact poison control immediately

Avoid contact with eyes. If contact occurs flush with water

Discontinue use and contact a health practitioner if irritation develops

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Wet skin and apply a sufficient amount on hands and forearms

Scrub well and rinse thoroughly after washing

INACTIVE INGREDIENT

OLIVE OIL
WALNUT OIL
JOJOBA OIL
RICE BRAN OIL
GAMOLENIC ACID
ALKYL (C12-15) BENZOATE
QUATERNIUM-15
EDETATE SODIUM
CITRIC ACID MONOHYDRATE
ALOE VERA LEAF
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)
ALLANTOIN
COCAMIDOPROPYL BETAINE
SODIUM LAURETH SULFATE
COCAMIDOPROPYL HYDROXYSULTAINE
POLYSORBATE 20
PEG-150 DISTEARATE
SODIUM LAUROYL SARCOSINATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFTCIDE 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55863-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.001 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WALNUT OIL (UNII: Y0P3555R51)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
RICE BRAN OIL (UNII: LZO6K1506A)
GAMOLENIC ACID (UNII: 78YC2MAX4O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
QUATERNIUM-15 (UNII: E40U03LEM0)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
ALLANTOIN (UNII: 344S277G0Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55863-155-51	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2017
2	NDC: 55863-155-62	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2017
3	NDC: 55863-155-65	800 mL in 1 BAG; Type 0: Not a Combination Product	04/10/2017
4	NDC: 55863-155-70	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/10/2017

Labeler - Erie Scientific LLC (361605223)

Establishment
Name	Address	ID/FEI	Business Operations
KUTOL PRODUCTS COMPANY		004236139	manufacture(55863-155)