CHEMSEPTIC- chloroxylenol soap 
Rochester Midland Corporation

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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Chemseptic 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, fragrance, FD and C yellow no.5, food red 10

Chemseptic 1 gallon

product label

Chemseptic  1 gallon label

CHEMSEPTIC 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59503-0544
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:59503-0544-1532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2004
2NDC:59503-0544-23785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2004
3NDC:59503-0544-318900 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2004
4NDC:59503-0544-4208200 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2004
5NDC:59503-0544-5946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2004
6NDC:59503-0544-62500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2004
7NDC:59503-0544-775600 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2004
8NDC:59503-0544-8132500 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2004
9NDC:59503-0544-9650 mL in 1 BAG; Type 0: Not a Combination Product03/30/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/30/2004
Labeler - Rochester Midland Corporation (002207041)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(59503-0544)

Revised: 12/2018
Document Id: bb7fa81f-b4fe-4440-bc2c-d2ed3da0c62e
Set id: f3109c8d-c684-47a7-b26a-32e3ba64b838
Version: 3
Effective Time: 20181226
 
Rochester Midland Corporation