Label: ANTIBACTERIAL FRESH PEAR- triclosan solution
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-184-08 - Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
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 August 2, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER (AQUA), SODIUM XYLENE SULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, GREEN 3 (CI 42053), YELLOW 10 (CI47005)
- LABEL COPY
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL FRESH PEAR
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-184 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.46 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F) CETYL ALCOHOL (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-184-08 222 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/03/2011 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture