CARROLLCLEAN- chloroxylenol (pcmx) soap
CarrollCLEAN LCC

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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Pink Antimicrobial Soap

Active ingredient

Chloroxylenol 0.25% w/v

Purpose

Antimicrobial

Uses

hand washing in public washrooms, work areas, healthcare facilities, office buildings, food service facilities, and wherever clealiness and antimicrobial properties are desired.

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 control center immediately.

Directions

apply small amount of product to hands
hold hands under water and work cleaner into lather
rinse with water and wipe clean

Other information

store at room temperature

Inactive ingredients:

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Dimethylol-5,5-dimethylhydantoin, Linear Ethoxylated Alcohol, Propylene Glycol, Polyethylene Glycol Distereate, Fragance, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methyllisothiazolinone, Isopropyl Myristate, Citric acid, FD & C Red #40, D & C Red #33

Pakage label

Clean N Fresh

CARROLLCLEAN
chloroxylenol (pcmx) soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73708-524
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.282 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.221 mL in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0004 mL in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0002 mL in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.334 mL in 100 mL
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)	0.317 mL in 100 mL
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)	7.85 mL in 100 mL
C9-11 PARETH-8 (UNII: 80E6PSE1XL)	0.242 mL in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.005 mL in 100 mL
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.099 mL in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.026 mL in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	4.132 mL in 100 mL
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)	0.038 mL in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	2.146 mL in 100 mL
WATER (UNII: 059QF0KO0R)	84.307 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73708-524-28	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/16/2020

Labeler - CarrollCLEAN LCC (081222623)

Registrant - CarrollCLEAN LCC (081222623)

Name	Address	ID/FEI	Business Operations
Establishment
CarrollCLEAN LCC		081222623	manufacture(73708-524)