Label: HEALTH SMART ANTIBACTERIAL LAVENDER CHAMOMILE- triclosan solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52862-309-75 - Packager: International Wholesale, Inc.
- 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 December 24, 2013
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information:
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Package Label
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INGREDIENTS AND APPEARANCE
HEALTH SMART ANTIBACTERIAL LAVENDER CHAMOMILE
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.15 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52862-309-75 221 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/24/2013 Labeler - International Wholesale, Inc. (161872676)