OSCEOLA SUPPLY INC 6176- chloroxylenol soap

Osceola Supply Inc 6176 by

Drug Labeling and Warnings

Osceola Supply Inc 6176 by is a Otc medication manufactured, distributed, or labeled by OSCEOLA SUPPLY, INC., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 61766176M4P5136.jpg

INGREDIENTS AND APPEARANCE

OSCEOLA SUPPLY INC 6176 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62672-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62672-300-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
2	NDC: 62672-300-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
3	NDC: 62672-300-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/22/2016
4	NDC: 62672-300-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/22/2016
5	NDC: 62672-300-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
6	NDC: 62672-300-07	700 mL in 1 BAG; Type 0: Not a Combination Product	07/22/2016
7	NDC: 62672-300-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/22/2016
8	NDC: 62672-300-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/22/2016
9	NDC: 62672-300-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
10	NDC: 62672-300-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/22/2016
11	NDC: 62672-300-13	800 mL in 1 BAG; Type 0: Not a Combination Product	07/22/2016
12	NDC: 62672-300-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
13	NDC: 62672-300-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
14	NDC: 62672-300-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
15	NDC: 62672-300-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/22/2016
16	NDC: 62672-300-55	2082 mL in 1 DRUM; Type 0: Not a Combination Product	07/22/2016
17	NDC: 62672-300-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
18	NDC: 62672-300-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2016
19	NDC: 62672-300-19	1890 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/22/2016
20	NDC: 62672-300-20	7560 mL in 1 DRUM; Type 0: Not a Combination Product	07/22/2016
21	NDC: 62672-300-35	1325 mL in 1 DRUM; Type 0: Not a Combination Product	07/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/22/2016

Labeler - OSCEOLA SUPPLY, INC. (809050479)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(62672-300)