PURE KLEEN- chloroxylenol soap

Pure Kleen by

Drug Labeling and Warnings

Pure Kleen by is a Otc medication manufactured, distributed, or labeled by Arrow-Magnolia International, Inc,, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, fragrance, FD and C yellow no.5, food red 10

Pure Kleen 6544 1 gal

6544F1S6046.jpg  Pure Kleen  1 gal   

INGREDIENTS AND APPEARANCE

PURE KLEEN 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76016-544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76016-544-06	1 in 1 BOX	04/15/2015
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 76016-544-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
3	NDC: 76016-544-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
4	NDC: 76016-544-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2015
5	NDC: 76016-544-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2015
6	NDC: 76016-544-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
7	NDC: 76016-544-07	700 mL in 1 BAG; Type 0: Not a Combination Product	04/15/2015
8	NDC: 76016-544-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2015
9	NDC: 76016-544-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2015
10	NDC: 76016-544-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
11	NDC: 76016-544-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/15/2015
12	NDC: 76016-544-13	800 mL in 1 BAG; Type 0: Not a Combination Product	04/15/2015
13	NDC: 76016-544-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
14	NDC: 76016-544-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
15	NDC: 76016-544-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
16	NDC: 76016-544-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2015
17	NDC: 76016-544-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	10/12/2015
18	NDC: 76016-544-08	1 in 1 BOX	04/15/2015
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC: 76016-544-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
20	NDC: 76016-544-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015
21	NDC: 76016-544-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/15/2015
22	NDC: 76016-544-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	04/15/2015
23	NDC: 76016-544-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	04/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2011

Labeler - Arrow-Magnolia International, Inc, (007330848)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(76016-544)