Label: FEIX BIOAZUFRE / BIOSULPHUR- sulfur soap
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Contains inactivated NDC Code(s)
NDC Code(s): 66854-002-01 - Packager: SPAI-SONS PHAMACEUTICAL INTERNATIONAL COSMETICS
- 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 April 25, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEIX BIOAZUFRE / BIOSULPHUR
sulfur soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66854-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 2 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) SODIUM PALMITATE (UNII: JQ43KP6296) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z) PARAFFIN (UNII: I9O0E3H2ZE) SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM ISETHIONATE (UNII: 3R36J71C17) POLYSORBATE 80 (UNII: 6OZP39ZG8H) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) METHYL GLUCETH-20 (UNII: J3QD0LD11P) GLYCERIN (UNII: PDC6A3C0OX) DIPYRITHIONE (UNII: 9L87N86R9A) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white (BEIGE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66854-002-01 70 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358H 05/01/2006 Labeler - SPAI-SONS PHAMACEUTICAL INTERNATIONAL COSMETICS (880172184) Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184) Establishment Name Address ID/FEI Business Operations SPAI-SONS PHARMACEUTICAL INTERNATIONAL COMSETICS 880172184 analysis, label, manufacture, pack