BAN-AID- chloroxylenol soap 
Pro Chem, 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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Ban-Aid 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

Ban-Aid 1 gallon

product label

Ban-Aid  1 gallon

BAN-AID 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63830-544
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:63830-544-061 in 1 BOX02/01/2007
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:63830-544-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2007
Labeler - Pro Chem, Inc. (061396065)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(63830-544)

Revised: 12/2018
Document Id: 98a93b39-5a0d-490b-8a18-97e4117cf9ea
Set id: a251093c-77d1-4a2b-ba3d-e8768656cf6c
Version: 3
Effective Time: 20181228
 
Pro Chem, Inc.