CLEAR CHOICE OUT OF SIGHT- chloroxylenol soap 
ABC Compounding Co., Inc.

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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Clear Choice Out of Sight 6544 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

Drug Facts Box OTC-Inactive Ingredient Section

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

Clear Choice Out of Sight 1 gallon bottle

product label

Clear Choice Out of Sight 1 gallon bottle Label

CLEAR CHOICE OUT OF SIGHT 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62257-950-061 in 1 BOX04/09/2014
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:62257-950-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
3NDC:62257-950-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
4NDC:62257-950-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/09/2014
5NDC:62257-950-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/09/2014
6NDC:62257-950-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
7NDC:62257-950-07700 mL in 1 BAG; Type 0: Not a Combination Product04/09/2014
8NDC:62257-950-092000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/09/2014
9NDC:62257-950-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/09/2014
10NDC:62257-950-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
11NDC:62257-950-121000 mL in 1 BAG; Type 0: Not a Combination Product04/09/2014
12NDC:62257-950-13800 mL in 1 BAG; Type 0: Not a Combination Product04/09/2014
13NDC:62257-950-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
14NDC:62257-950-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
15NDC:62257-950-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
16NDC:62257-950-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/09/2014
17NDC:62257-950-55208200 mL in 1 DRUM; Type 0: Not a Combination Product04/09/2014
18NDC:62257-950-081 in 1 BOX04/09/2014
181000 mL in 1 BAG; Type 0: Not a Combination Product
19NDC:62257-950-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
20NDC:62257-950-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2014
21NDC:62257-950-1918900 mL in 1 CONTAINER; Type 0: Not a Combination Product04/09/2014
22NDC:62257-950-2075600 mL in 1 DRUM; Type 0: Not a Combination Product04/09/2014
23NDC:62257-950-35132500 mL in 1 DRUM; Type 0: Not a Combination Product04/09/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/09/2014
Labeler - ABC Compounding Co., Inc. (003284353)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62257-950)

Revised: 12/2018
Document Id: ebd28b96-0b60-47b4-8e7d-fe6f8dd2f96d
Set id: ae5ca5dd-c8ea-4558-84db-4c2b5835e4e9
Version: 3
Effective Time: 20181226
 
ABC Compounding Co., Inc.