Label: UNITEX ANTIBACTERIAL LOTIONHANDSOAP- chloroxylenol liquid
- NDC Code(s): 84955-841-04
- Packager: Jon-Don LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 28, 2024
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- 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
-
INGREDIENTS AND APPEARANCE
UNITEX ANTIBACTERIAL LOTIONHANDSOAP
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84955-841 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 4 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185) SODIUM BENZOATE (UNII: OJ245FE5EU) 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F) BENZYL SALICYLATE (UNII: WAO5MNK9TU) 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) HEXYL SALICYLATE (UNII: 8F78EY72YL) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) SODIUM CHLORIDE (UNII: 451W47IQ8X) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU) SODIUM CARBONATE (UNII: 45P3261C7T) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SODIUM HYDROXIDE (UNII: 55X04QC32I) CALCIUM SILICATE (UNII: S4255P4G5M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) LINALOOL, (+/-)- (UNII: D81QY6I88E) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) BENZYL ACETATE (UNII: 0ECG3V79ZJ) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y) DIHYDROMYRCENOL (UNII: 46L1B02ND9) HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS) VERDYL ACETATE (UNII: 5232EN3X2F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84955-841-04 3780 mL in 1 JUG; Type 0: Not a Combination Product 11/12/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 11/12/2012 Labeler - Jon-Don LLC (091773820) Registrant - Betco corporation, Ltd. (005050158) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 005050158 manufacture(84955-841) , label(84955-841)