Label: TOPCARE ANTIBACTERIAL FRESH PEAR- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-195-32 - 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 October 26, 2012
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- ACTIVE INGREDIENT
- USES
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER (AQUA), SODIUM XYLENESULFONATE, 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 (CI 47005).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE ANTIBACTERIAL FRESH PEAR
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-195 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 4.6 mg in 1 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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:36800-195-32 946 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/26/2012 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(36800-195)