GYNOX-SOFT

Manufacturer: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date: 2012-06-07
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:25

Label at a glance#

ProductGYNOX-SOFT

Active ingredientBORIC ACID

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product must be out of reach of children

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-003-01	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-02	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-03	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-04	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-05	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-06	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-07	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-09	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-10	2019-11-13	C162847	48780-1	97449f38-bd11-f6ea-e053-dbdaa90aa703	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-003-01	GYNOX-SOFT	210 mL in 1 BOTTLE	EMULSION	210	1
66854-003-02	GYNOX-SOFT	250 mL in 1 BOTTLE	EMULSION	250	1
66854-003-03	GYNOX-SOFT	260 mL in 1 BOTTLE	EMULSION	260	1
66854-003-04	GYNOX-SOFT	270 mL in 1 BOTTLE	EMULSION	270	1
66854-003-05	GYNOX-SOFT	400 mL in 1 BOTTLE	EMULSION	400	1
66854-003-06	GYNOX-SOFT	515 mL in 1 BOTTLE	EMULSION	515	1
66854-003-07	GYNOX-SOFT	1000 mL in 1 BOTTLE	EMULSION	1000	1
66854-003-08	GYNOX-SOFT	12 mL in 1 BAG	EMULSION	12	1
66854-003-09	GYNOX-SOFT	30 in 1 BOX	EMULSION	30	1
66854-003-10	GYNOX-SOFT	500 mL in 1 BOTTLE	EMULSION	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-003	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 10 package rows	20120630_22e79312-b49c-4392-8a7a-a9bd04e9e2df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BORIC ACID	ACTIVE INGREDIENT	R57ZHV85D4	1
BORIC ACID	ACTIVE MOIETY	R57ZHV85D4	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	1
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	1
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

GYNOX-SOFT
BORIC ACID
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-003	66854-003-01, 66854-003-02, 66854-003-03, 66854-003-04, 66854-003-05, 66854-003-06, 66854-003-07, 66854-003-08, 66854-003-09, 66854-003-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BORIC ACID	R57ZHV85D4	ACTIB
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
SODIUM LAUROYL LACTYLATE	7243K85WFO	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCOL DISTEARATE	13W7MDN21W	IACT
COCO GLUCOSIDE	ICS790225B	IACT
GLYCERYL OLEATE	4PC054V79P	IACT
CHAMOMILE	FGL3685T2X	IACT
PEG-120 METHYL GLUCOSE DIOLEATE	YM0K64F20V	IACT
FD&C RED NO. 40	WZB9127XOA	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CAPSULE / ORAL	3.5 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL OLEATE	GLYCERYL OLEATE	4PC054V79P	GEL / TOPICAL	1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL OLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL OLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERYL OLEATE	GLYCERYL OLEATE	4PC054V79P	SPRAY / TOPICAL	0.95 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
63764ca7-1280-4fec-a562-b73eb70644b3			22e79312-b49c-4392-8a7a-a9bd04e9e2df	2012-06-07	Warnings	Exact identifier spl id: 63764ca7-1280-4fec-a562-b73eb70644b3 spl set id: 22e79312-b49c-4392-8a7a-a9bd04e9e2df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.