FDA Device Intelligence
HomeNEO COSMETIQUE › Exsens Aloe Vera Gel lubrifiant intime

Exsens Aloe Vera Gel lubrifiant intime

NEO COSMETIQUE · Model 1 · UDI-DI 03701411600014

NUC
1
510(k) clearances
175
Adverse events (1 deaths)
7
Recalls
124
Facilities

Description

INTENDED USE This Exsens product is a water based intimate lubricant intended for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. DIRECTIONS Apply desired amount. Reapply as desired. This product is compatible with natural rubber latex condoms and polyisoprene male condoms. This product is not compatible with polyurethane condoms. WARNING This product is not a contraceptive and does not contain spermicide. Avoid contact with the eyes. Keep out of reach of children. Use on healthy intimate mucous. If irritation or discomfort occurs discontinue use immediately and consult a physician. Very slippery on surfaces, clean spills immediately.

Recalls

DateFirmReason
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2012-07-02Mc-NEIL-PPC, Inc.Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device
2009-07-10Memphis Fertility Laboratory IncProduct was marketed without a 510(k).
2008-09-22INGfertility, LLCProduct contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.