GYNOX-SOFT - boric acid emulsion 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene

GYNOX-SOFT is a foaming emulsion with Boric acid that is a antiseptic agent to control the microbial load present in the intimate area.

GYNOX SOFT NEUTRAL, SCENTED OR TEEN,  bubble bath is an antibacterial action, cleaning, fungicidal, and antibacterial that can be used by the whole family, including new borns.

This product must be out of reach of children

GYNOX-SOFT is intimate hygiene foaming emulsion and body for men, women and teenagers of antibacterial action. Is pH balanced, is in daily use before, during and after the menstrual cycle, deep asepsis of hands skin complaints and scalp.

Suspend its use if you observed any desfavorable reaction. This product may be irritate your skin if you do not follow the recommended instructions. Contact with eyes may produce irritation and burning sensation; if this occurs flush your eyes immediately with fresh water.

This product is for topical application. Add in the application area amount of product, rub gently to obtain foam and rinse.

This product is an emulsion, made with ingredients that provide moisturization, and protection in the intimate area. Is non toxic and has no known contraindications.


IMAGE OF THE LABEL


IMAGE OF THE LABEL


IMAGE OF THE LABEL

IMAGE OF THE LABEL


GYNOX-SOFT 
boric acid emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID7 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (BEIGE) , pink (PINK) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-003-01210 mL in 1 BOTTLE
2NDC:66854-003-02250 mL in 1 BOTTLE
3NDC:66854-003-03260 mL in 1 BOTTLE
4NDC:66854-003-04270 mL in 1 BOTTLE
5NDC:66854-003-05400 mL in 1 BOTTLE
6NDC:66854-003-06515 mL in 1 BOTTLE
7NDC:66854-003-071000 mL in 1 BOTTLE
8NDC:66854-003-0930 in 1 BOX
8NDC:66854-003-0812 mL in 1 BAG
9NDC:66854-003-10500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/30/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 6/2012
Document Id: 63764ca7-1280-4fec-a562-b73eb70644b3
Set id: 22e79312-b49c-4392-8a7a-a9bd04e9e2df
Version: 1
Effective Time: 20120607
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS