Gynol II Extra Strength: Package Insert and Label Information

GYNOL II EXTRA STRENGTH- nonoxynol-9 gel
Caldwell Consumer Health LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

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

Uses

For the prevention of pregnancy.

With condom or alone.

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.

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.

mm1.jpg

Carton Label
(click image for full-size original)

MM2.jpg

Bottle Label
(click image for full-size original)

GYNOL II EXTRA STRENGTH
nonoxynol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:34362-0302
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NONOXYNOL-9 (NONOXYNOL-9) NONOXYNOL-9 3.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
SORBITOL
SORBIC ACID
METHYLPARABEN
LACTIC ACID
POVIDONE K29/32
PROPYLENE GLYCOL
CARBOXYMETHYLCELLULOSE SODIUM
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:34362-0302-5 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR (34362-0302-1)
1 NDC:34362-0302-1 81 g in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (34362-0302-5)
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 Operations
DPT Laboratories 832224526 manufacture (34362-0302), pack (34362-0302)

Revised: 12/2020 Caldwell Consumer Health LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.