Label: GYNOX-SOFT- boric acid emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 66854-003-01, 66854-003-02, 66854-003-03, 66854-003-04, view more66854-003-05, 66854-003-06, 66854-003-07, 66854-003-08, 66854-003-09, 66854-003-10 - Packager: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 7, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
GYNOX-SOFT
boric acid emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66854-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 7 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) COCO DIETHANOLAMIDE (UNII: 92005F972D) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCO GLUCOSIDE (UNII: ICS790225B) GLYCERYL OLEATE (UNII: 4PC054V79P) CHAMOMILE (UNII: FGL3685T2X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color white (BEIGE) , pink (PINK) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66854-003-01 210 mL in 1 BOTTLE 2 NDC:66854-003-02 250 mL in 1 BOTTLE 3 NDC:66854-003-03 260 mL in 1 BOTTLE 4 NDC:66854-003-04 270 mL in 1 BOTTLE 5 NDC:66854-003-05 400 mL in 1 BOTTLE 6 NDC:66854-003-06 515 mL in 1 BOTTLE 7 NDC:66854-003-07 1000 mL in 1 BOTTLE 8 NDC:66854-003-09 30 in 1 BOX 8 NDC:66854-003-08 12 mL in 1 BAG 9 NDC:66854-003-10 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/30/2012 Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184) Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184) Establishment Name Address ID/FEI Business Operations SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS 880172184 analysis, label, manufacture, pack