PALM - 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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Palm 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, DMDM hydantoin, citric acid, fragrance, FD and C yellow no.5, food red 10

Palm 6544 Drug Facts and Label

product label

6544 Palm Label

PALM  
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-544
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:62257-544-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
2NDC:62257-544-07700 mL in 1 BAG; Type 0: Not a Combination Product12/21/1998
3NDC:62257-544-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product12/21/1998
4NDC:62257-544-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
5NDC:62257-544-121000 mL in 1 BAG; Type 0: Not a Combination Product12/21/1998
6NDC:62257-544-061 in 1 BOX12/21/1998
6NDC:62257-544-13800 mL in 1 BAG; Type 0: Not a Combination Product
7NDC:62257-544-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
8NDC:62257-544-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product12/21/1998
9NDC:62257-544-55208200 mL in 1 DRUM; Type 0: Not a Combination Product12/21/1998
10NDC:62257-544-35132500 mL in 1 DRUM; Type 0: Not a Combination Product12/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/21/1998
Labeler - ABC Compounding Co., Inc. (003284353)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62257-544)

Revised: 12/2018
Document Id: c0c10357-0bdb-464e-817d-aad253ebff03
Set id: a641ad83-1a28-4be7-a5ce-7ef5a192f326
Version: 4
Effective Time: 20181226
 
ABC Compounding Co., Inc.