Gynol II

Manufacturer: Caldwell Consumer Health LLC | Lornamead | DPT Laboratories
Effective date: 2020-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 23:34:34

Label at a glance#

ProductGynol II Extra Strength

Active ingredientNONOXYNOL-9

Label structure8 sections

Indications and uses

For the prevention of pregnancy. With condom or alone.

Dosage and administration

For maximum protection against unwanted pregnancy, follow the enclosed directions exactly. Each applicatorful is effective immediately and up to one hour after application.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Nonoxynol-9 (3%) (100 mg per applicatorful)............................................Vaginal Contraceptive

Uses

OTC - PURPOSE SECTION

For the prevention of pregnancy.

With condom or alone.

WARNINGS SECTION

For vaginal use only.

Not for rectal (anal) use.

Sexually transmitted diseases (STDs) alert:

This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.

Do not use if you or your sex partner has HIV/AIDS. If you do not know if your sex partner is infected, choose another form of birth control.

Stop use and ask a doctor if you or your partner gets burning, itching, a rash, or other irritation or the vagina or penis.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

For maximum protection against unwanted pregnancy, follow the enclosed directions exactly.

Each applicatorful is effective immediately and up to one hour after application.

DOSAGE & ADMINISTRATION SECTION

Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on the package insert).

An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.

Other Information

OTHER SAFETY INFORMATION

When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS.

Store at room temperature, 20° - 25° C (68° -77° F). Avoid exposure to extremes of hot or cold.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactic acid, methylparaben, povidone, propylene glycol, purified water, sodium carboxymethylcellulose, sorbic acid, sorbitol solution.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mm1.jpg

Carton Label

MM2.jpg
Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1250090	GYNOL II Extra Strength 3 % Vaginal Gel	PSN	7
312029	nonoxynol-9 3 % Vaginal Gel	PSN	7
1250090	nonoxynol-9 0.03 MG/MG Vaginal Gel [Gynol II]	SBD	7
312029	nonoxynol-9 0.03 MG/MG Vaginal Gel	SCD	7
1250090	Gynol II 0.03 MG/MG Vaginal Gel	SY	7
1250090	Gynol II Extra Strength 3 % Vaginal Gel	SY	7
312029	nonoxynol-9 3 % Vaginal Gel	SY	7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
34362-0302-5	2022-01-28	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts
34362-0302-5	2020-12-01	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts
34362-0302-5	2020-01-31	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
34362-0302-1	Gynol IIExtra Strength	81 g in 1 BOTTLE, WITH APPLICATOR	GEL	81		7
34362-0302-5	Gynol IIExtra Strength	1 in 1 CARTON	GEL	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
34362-0302	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	7	Legacy NDC, 2 package rows	20201203_eaf86a36-0573-4c39-9324-88919c4d009b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
34362-0302-1	GM - Gram	34362-0302	67da3f90-9ddf-4646-807a-abbb4d77ffef	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NONOXYNOL-9	ACTIVE INGREDIENT	48Q180SH9T	3
NONOXYNOL-9	ACTIVE MOIETY	48Q180SH9T	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Gynol II Extra Strength
Nonoxynol
NONOXYNOL-9
WATER
SORBITOL
SORBIC ACID
METHYLPARABEN
LACTIC ACID
POVIDONE K29/32
PROPYLENE GLYCOL
CARBOXYMETHYLCELLULOSE SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
34362-0302	34362-0302-1, 34362-0302-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NONOXYNOL-9	48Q180SH9T	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SORBIC ACID	X045WJ989B	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
LACTIC ACID	33X04XA5AT	IACT
POVIDONE K29/32	390RMW2PEQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	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 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	LOTION / TOPICAL	5.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CREAM / VAGINAL	0.81 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		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
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAMUSCULAR	1.16 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CREAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 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
3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941			eaf86a36-0573-4c39-9324-88919c4d009b	2020-12-01	Warnings	Exact identifier spl id: 3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941 spl set id: eaf86a36-0573-4c39-9324-88919c4d009b

Reported adverse events (FAERS/openFDA)#

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