OSCEOLA SUPPLY INC 6176- chloroxylenol soap 
OSCEOLA SUPPLY, 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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Medicated Lotion Soap 6176 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.6%


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

wet hands and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, propylene glycol, sodium chloride, PEG-75 lanolin, sodium styrene/PEG-10 maleate/nonoxynol-10 maleate/acrylates copolymer, boric acid, fragrance, methylparaben, propylparaben, aloe barbadensis

Medicated Lotion Soap 6176 Label

Medicated Lotion Soap 6176image description6176M4P5136.jpg

OSCEOLA SUPPLY INC 6176 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62672-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62672-300-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
2NDC:62672-300-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
3NDC:62672-300-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
4NDC:62672-300-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
5NDC:62672-300-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
6NDC:62672-300-07700 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
7NDC:62672-300-092000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
8NDC:62672-300-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
9NDC:62672-300-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
10NDC:62672-300-121000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
11NDC:62672-300-13800 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
12NDC:62672-300-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
13NDC:62672-300-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
14NDC:62672-300-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
15NDC:62672-300-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
16NDC:62672-300-552082 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
17NDC:62672-300-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
18NDC:62672-300-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
19NDC:62672-300-191890 mL in 1 CONTAINER; Type 0: Not a Combination Product07/22/2016
20NDC:62672-300-207560 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
21NDC:62672-300-351325 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/22/2016
Labeler - OSCEOLA SUPPLY, INC. (809050479)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62672-300)

Revised: 7/2016
Document Id: 17d206d2-a7d5-4605-9626-b4c5ec099c6f
Set id: a7dcc6b1-655d-41b3-ab97-913bc4aae01f
Version: 1
Effective Time: 20160722
 
OSCEOLA SUPPLY, INC.