Label: ANTIBACTERIAL- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-141-50 - Packager: BJWC
- 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 July 23, 2010
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- Active Ingredient
- Purpose
- Warnings
- Questions/Comments?
- Directions
- Uses
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Inactive Ingredeints
Water (Aqua), Sodium Laureth Sulfate, Lauramide DEA, Cocamidopropyl Betaine, Decyl Glucoside, Polyquaternium-7, Saccharomyces, Hydrolyzed Vegetable Protein, Camellia Sinensis (Green Tea) Leaf Extract, Sodium Bicarbonate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Tetrasodium EDTA, Sodium Chloride, Fragrance (Parfum), DMDM Hydantoin, Citric Acid, Red 33 (CI 17200), Blue 1 (CI 42090).
- Package Front and Back Labels
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL WITH LIGHT MOISTURIZERS
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.115 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) NIACINAMIDE (UNII: 25X51I8RD4) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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:68391-141-50 3780 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 07/23/2010 Labeler - BJWC (159082692)