Label: ANTIBACTERIAL SKIN CLEANSER- chloroxylenol soap
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NDC Code(s):
65601-708-04,
65601-708-10,
65601-708-19,
65601-708-29, view more65601-708-41, 65601-708-55, 65601-708-88
- Packager: Betco Corporation, Ltd.
- 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 September 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Uses
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Warnings
- For external use only.
- Avoid contact with eyes.
- Children under the age of 6 should be supervised by an adult when using this product.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- Inactive Ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL SKIN CLEANSER
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-708 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) ALCOHOL (UNII: 3K9958V90M) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM NITRATE (UNII: 77CBG3UN78) DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R) ETHYL BUTYRATE (UNII: UFD2LZ005D) SODIUM FERROCYANIDE (UNII: 5HT6X21AID) ETHYL ACETOACETATE (UNII: IZP61H3TB1) LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU) SODIUM CARBONATE (UNII: 45P3261C7T) GLYCOL DISTEARATE (UNII: 13W7MDN21W) .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A) CHLOROACETIC ACID (UNII: 5GD84Y125G) IONONE (UNII: QP734LIN1K) BENZYL BENZOATE (UNII: N863NB338G) MYRCENE (UNII: 3M39CZS25B) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYL ANTHRANILATE (UNII: 981I0C1E5W) DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H) CALCIUM SILICATE (UNII: S4255P4G5M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYL ALCOHOL (UNII: Y4S76JWI15) ETHYLENE OXIDE (UNII: JJH7GNN18P) LINALOOL, (+/-)- (UNII: D81QY6I88E) DIOXANE (UNII: J8A3S10O7S) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-708-04 3780 mL in 1 JUG; Type 0: Not a Combination Product 02/01/2016 2 NDC:65601-708-19 900 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2016 3 NDC:65601-708-41 2000 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2016 07/15/2020 4 NDC:65601-708-55 207900 mL in 1 DRUM; Type 0: Not a Combination Product 02/01/2016 5 NDC:65601-708-10 1100 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2016 6 NDC:65601-708-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 11/12/2012 7 NDC:65601-708-88 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(65601-708) , pack(65601-708) , label(65601-708)