Label: ROYAL ANTIBACTERIAL (COCONUT AND LIME)- triclosan gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-600-01 - Packager: Filo America
- 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 June 4, 2015
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROYAL ANTIBACTERIAL (COCONUT AND LIME)
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-600-01 221 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/04/2015 Labeler - Filo America (943873703) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(50438-600)