Label: TOPICLEAR XTRA BEAUTY- hydroquinone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66129-035-25 - Packager: International Beauty Exchange
- 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 8, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS
- DO NOT USE
- WHEN USING
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPICLEAR XTRA BEAUTY
hydroquinone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66129-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 10 mL in 500 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 mL in 500 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALLANTOIN (UNII: 344S277G0Z) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHLOROCRESOL (UNII: 36W53O7109) CARROT (UNII: L56Z1JK48B) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66129-035-25 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 01/01/2011 Labeler - International Beauty Exchange (966261273) Establishment Name Address ID/FEI Business Operations JABONES PARDO SA 462018250 manufacture