Label: AROMAFIELDS JASMINE SCENTED ANTI-BACTERIAL HAND- triclosan lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49371-044-01 - Packager: ALILY (ZHANGZHOU) BATH PRODUCTS LTD.
- 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 5, 2010
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
Water (aqua), Mineral Oil, Glycerin, Cetearyl Alcohol, Petrolatum, Isopropyl Palmitate, Stearic Acid, Ceteareth-25, Cetearith-6, Glyceryl Stearate SE, Fragrance, Methylparaben, Carbomer, Triethanolamine, Propylparaben, Diazolidinyl Urea, Disodium EDTA, FD and C Yellow No. 5, FD and C Blue No. 1
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INGREDIENTS AND APPEARANCE
AROMAFIELDS JASMINE SCENTED ANTI-BACTERIAL HAND
triclosan lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49371-044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 82.1095 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 3 g in 100 g TROLAMINE (UNII: 9O3K93S3TK) 0.12 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) 5 g in 100 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.5 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) 1.5 g in 100 g FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0004 g in 100 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 g in 100 g ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 1.0 g in 100 g STEARIC ACID (UNII: 4ELV7Z65AP) 1.0 g in 100 g CETEARETH-30 (UNII: 1R9DCZ5FOX) 1.0 g in 100 g CETEARETH-12 (UNII: 7V4MR24V5P) 1.0 g in 100 g GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.8 g in 100 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g in 100 g CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.12 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g in 100 g DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.1 g in 100 g EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g in 100 g JASMINE (UNII: 0Q8K841432) 0.2 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49371-044-01 500 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 06/20/2010 Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269) Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269) Establishment Name Address ID/FEI Business Operations ALILY (ZHANGZHOU) BATH PRODUCTS LTD. 531064269 manufacture