Label: STUDIO 35 AMBER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-7215-60 - Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated July 9, 2013
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS:
WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200).
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INGREDIENTS AND APPEARANCE
STUDIO 35 AMBER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) GLYCERIN (UNII: PDC6A3C0OX) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM SULFATE (UNII: 0YPR65R21J) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7215-60 1650 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 07/08/2013 Labeler - WALGREEN COMPANY (008965063) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HALTH AND BEAUTY CARE 201901209 manufacture(0363-7215)