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GYNOX-SOFT

Medically reviewed on June 7, 2018

Dosage form: emulsion
Ingredients: BORIC ACID 7mg in 100mL
Labeler: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
NDC Code: 66854-003

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.

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




GYNOX-SOFT 
boric acid emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORIC ACID (BORIC ACID) BORIC ACID7 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
DECYL GLUCOSIDE 
SODIUM LAUROYL LACTYLATE 
COCO DIETHANOLAMIDE 
CALENDULA OFFICINALIS FLOWER 
PROPYLENE GLYCOL 
GLYCOL DISTEARATE 
COCO GLUCOSIDE 
GLYCERYL OLEATE 
CHAMOMILE 
PEG-120 METHYL GLUCOSE DIOLEATE 
FD&C RED NO. 40 
Product Characteristics
Colorwhite (BEIGE) , pink (PINK) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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 BAG (BAG) 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/FEIOperations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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