Label: ACTIVE 4- hydroquinone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67226-2140-6 - Packager: Vivier Pharma, 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 November 8, 2013
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- Active Ingredient
- Indication
- Indication
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Precautions
For external use only. Use only on the advice of a physician. A mild transient stinging may occur for people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid usage around the eyes and lips.
- Precautions
- Directions
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Non-Medicinal Ingredients
Butylated Hydroxy Toluene, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance/Parfum, Glycerin, Lactic Acid, L-Ascorbic Acid USP, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Triethanolamine Salicylate, Water/Eau.
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INGREDIENTS AND APPEARANCE
ACTIVE 4
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) ASCORBIC ACID (UNII: PQ6CK8PD0R) METHYLPARABEN (UNII: A2I8C7HI9T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM METABISULFITE (UNII: 4VON5FNS3C) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE SALICYLATE (UNII: H8O4040BHD) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2140-6 1 in 1 BOX 1 60 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 05/30/2014 Labeler - Vivier Pharma, Inc. (250996550) Establishment Name Address ID/FEI Business Operations Vivier Pharma, Inc. 250996550 manufacture(67226-2140)
