HIGH FOAMING ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap 
Pro Source Distributors, 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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High Foaming Antiseptic Hand and Body Wash 6876

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, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

High Foaming Antiseptic Hand and Body Wash 6876

product label

High Foaming Antiseptic Hand and Body Wash 6876

HIGH FOAMING ANTISEPTIC HAND AND BODY WASH 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72234-876
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)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ACID RED 1 (UNII: 3365R6427R)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72234-876-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/19/2018
2NDC:72234-876-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2018
3NDC:72234-876-121000 mL in 1 BAG; Type 0: Not a Combination Product04/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/19/2018
Labeler - Pro Source Distributors, Inc. (837372085)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(72234-876)

Revised: 12/2018
Document Id: ebb6760d-3da4-4c83-af67-120c2c736ef9
Set id: f8b63a2b-0063-4414-919d-c068fcd31ee5
Version: 6
Effective Time: 20181227
 
Pro Source Distributors, Inc.