Active Ingredient
Nonoxynol-9 (4%) (100 mg per applicatorful)............................................Vaginal Contraceptive
Conceptrol
FDA Label NDC 34362-0300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caldwell Consumer Health Llc for the product Conceptrol (NDC 34362-0300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, warnings, otc - keep out of reach of children, directions, dosage & administration, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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.
Package Label.Principal Display Panel
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