Label: ANTIBACTERIAL SPARKLING MIST- triclosan solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68196-804-24 - Packager: SAM'S WEST 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 June 17, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS, SADARIFFA FLOWER EXTRACT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TETRASODIUM EDTA, SODIUM CHLORIDE, BLUE1, RED 33
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL SPARKLING MIST
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-804 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.15 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PEG-8 DIOLEATE (UNII: 6JR5A7273E) GLYCERIN (UNII: PDC6A3C0OX) INDELOXAZINE HYDROCHLORIDE (UNII: 15QZ6NE84E) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NIACINAMIDE (UNII: 25X51I8RD4) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EDETATE SODIUM (UNII: MP1J8420LU) GINGER (UNII: C5529G5JPQ) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) SODIUM CHLORIDE (UNII: 451W47IQ8X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-804-24 720 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/17/2011 Labeler - SAM'S WEST INC (051957769) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture