GYNOL II EXTRA STRENGTH- nonoxynol gel

Gynol II by

Drug Labeling and Warnings

Gynol II by is a Otc medication manufactured, distributed, or labeled by Caldwell Consumer Health LLC, Lornamead, DPT Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Uses

For the prevention of pregnancy.

With condom or alone.

WARNINGS

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.

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

Directions

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

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

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

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

GYNOL II  EXTRA STRENGTH
nonoxynol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0302
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T)	NONOXYNOL-9	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
LACTIC ACID (UNII: 33X04XA5AT)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0302-5	1 in 1 CARTON
1	NDC: 34362-0302-1	81 g in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2011

Labeler - Caldwell Consumer Health LLC (828558713)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
DPT Laboratories		832224526	manufacture(34362-0302) , pack(34362-0302)