GYNOX-SOFT: Package Insert and Label Information

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.

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.


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GYNOX-SOFT
boric acid emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66854-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BORIC ACID (BORIC ACID) BORIC ACID 7 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
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
Color white (BEIGE) , pink (PINK) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66854-003-01 210 mL in 1 BOTTLE None
2 NDC:66854-003-02 250 mL in 1 BOTTLE None
3 NDC:66854-003-03 260 mL in 1 BOTTLE None
4 NDC:66854-003-04 270 mL in 1 BOTTLE None
5 NDC:66854-003-05 400 mL in 1 BOTTLE None
6 NDC:66854-003-06 515 mL in 1 BOTTLE None
7 NDC:66854-003-07 1000 mL in 1 BOTTLE None
8 NDC:66854-003-09 30 BAG (BAG) in 1 BOX contains a BAG (66854-003-08)
8 NDC:66854-003-08 12 mL in 1 BAG This package is contained within the BOX (66854-003-09)
9 NDC:66854-003-10 500 mL in 1 BOTTLE None
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 Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS 880172184 analysis, label, manufacture, pack

Revised: 06/2012 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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