CLEANSE- chloroxylenol soap

Cleanse by

Drug Labeling and Warnings

Cleanse by is a Otc medication manufactured, distributed, or labeled by 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

Cleanse 6363 18 oz bottle

636318PS.jpg  Cleanse 18 oz bottle 

INGREDIENTS AND APPEARANCE

CLEANSE  
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62257-363
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62257-363-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC: 62257-363-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC: 62257-363-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC: 62257-363-01	1200 mL in 1 CARTRIDGE
5	NDC: 62257-363-03	350 mL in 1 CARTRIDGE
6	NDC: 62257-363-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC: 62257-363-07	700 mL in 1 BAG
8	NDC: 62257-363-09	2000 mL in 1 CARTRIDGE
9	NDC: 62257-363-10	1000 mL in 1 CARTRIDGE
10	NDC: 62257-363-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC: 62257-363-12	1000 mL in 1 BAG
12	NDC: 62257-363-13	800 mL in 1 BAG
13	NDC: 62257-363-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC: 62257-363-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC: 62257-363-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC: 62257-363-27	800 mL in 1 CARTRIDGE
17	NDC: 62257-363-55	208200 mL in 1 DRUM
18	NDC: 62257-363-08	1 in 1 BOX
18		1000 mL in 1 BAG
19	NDC: 62257-363-16	236 mL in 1 BOTTLE, PLASTIC
20	NDC: 62257-363-18	50 mL in 1 BOTTLE, PLASTIC
21	NDC: 62257-363-19	18900 mL in 1 CONTAINER
22	NDC: 62257-363-20	75600 mL in 1 DRUM
23	NDC: 62257-363-35	132500 mL in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(62257-363)