CARROLLCLEAN (chloroxylenol- pcmx soap

CarrollCLEAN by

Drug Labeling and Warnings

CarrollCLEAN by is a Otc medication manufactured, distributed, or labeled by CarrollCLEAN LCC, CarrollCLEAN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 whatever cleanliness 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 section

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

Package label

INGREDIENTS AND APPEARANCE

CARROLLCLEAN 
chloroxylenol (pcmx) soap

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

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)	7.85 mL  in 100 mL
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.099 mL  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	4.132 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
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)	0.317 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	84.307 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.026 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	2.146 mL  in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0004 mL  in 100 mL
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)	0.038 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.221 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73708-524-17	800 mL in 1 BAG; Type 0: Not a Combination Product	11/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/06/2020

Labeler - CarrollCLEAN LCC (081222623)

Registrant - CarrollCLEAN LCC (081222623)

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