Gynol II description, usages, side effects, indications, overdosage, supplying and lots more!

Gynol II

Caldwell Consumer Health LLC
Lornamead

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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Gynol II

Nonoxynol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:34362-0302
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NONOXYNOL-9 3.0 g

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
sorbic acid
METHYLPARABEN
LACTIC ACID
POVIDONE K29/32
propylene glycol
CARBOXYMETHYLCELLULOSE SODIUM

Product Characteristics

Color
white

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 2011-05-01


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