Label: GREAT VALUE GREEN APPLE SCENT- chloroxylenol green apple soap
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Contains inactivated NDC Code(s)
NDC Code(s): 63691-034-10, 63691-034-30 - Packager: Sun Products Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 7, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient
Chloroxylenol 0.30%
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.
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, FD&C Blue No. 1
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GREAT VALUE GREEN APPLE SCENT
chloroxylenol green apple soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63691-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ALCOHOL (UNII: 3K9958V90M) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63691-034-10 709 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2016 2 NDC:63691-034-30 1774 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2016 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/30/2016 Labeler - Sun Products Corporation (070931480)
