GREAT VALUE ORANGE SCENT- orange chloroxylenol soap
Sun Products Corporation

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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Active ingredient

Chloroxylenol 0.30%

Use helps fight germs on hands when used as a hand soap

For external use only

Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Directions wet hands and forearms. Apply 5 mL or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Dishwashing Liquid and Antibacterial hand soap

Inactive ingredients Water, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, D&C Red No. 33

Questions? 1-877-505-2267

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GREAT VALUE ORANGE SCENT
orange chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63691-033
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE SODIUM (UNII: MP1J8420LU)
ALCOHOL (UNII: 3K9958V90M)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63691-033-10	709 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/01/2016

Labeler - Sun Products Corporation (070931480)