GYNOX-SOFT- boric acid emulsion

GYNOX-SOFT by

Drug Labeling and Warnings

GYNOX-SOFT by is a Otc medication manufactured, distributed, or labeled by SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

This product must be out of reach of children

INDICATIONS & USAGE

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.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

GYNOX-SOFT 
boric acid emulsion

Product 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