SOFTCIDE-ES- softcide-es liquid 
Erie Scientific, LLC

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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SoftCIDE-ES

Chloroxylenol 0.3% w/w

Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E Acetate), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5

Wet skin and apply a sufficient amount on hands and forearms. Scrub well and rinse thoroughly after washing.

Handwash to help reduce bacteria that can potentially cause disease.

Handwash to help reduce bacteria that can potentially cause disease.

Avoid contact with the eyes. If contact occurs, flush eyes with water.

Discontinue use and consult a health practitioner if irritation develops. If swallowed seek medical help or contact Posion Control immediately. Keep out of reach of children.

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

Avoid contact with eyes. If contact occurs, flush eyes with water.

For external use only.

Avoid contact with the eyes. If contact occurs, flush eyes with water.

Discontinue use and consult a health practitioner if irritation develops.

If swallowed seek medical help or contact Posion Control immediately.

Keep out of reach of children.

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SOFTCIDE-ES 
softcide-es liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55863-281
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL12.604 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
TALL OIL (UNII: 1GX6Z36A79)  
COCONUT ACID (UNII: 40U37V505D)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55863-281-27800 mL in 1 BAG
2NDC:55863-281-32946 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/13/2013
Labeler - Erie Scientific, LLC (361605223)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(55863-281) , pack(55863-281) , analysis(55863-281)

Revised: 7/2013
Document Id: 5de72152-9b3f-426d-9916-df7e9ef384b4
Set id: 152c8952-4fd6-4595-8039-502021c4f96e
Version: 1
Effective Time: 20130723
 
Erie Scientific, LLC