Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Endure Holdings, LLC
TOPICAL
OTC DRUG
Topical Anesthetic To help prevention of premature ejaculation
OTC monograph final
ENDURE MALE GENITAL DESENSITIZING- LIDOCAINE HYDROCHLORIDE SPRAY ENDURE HOLDINGS, 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._ ---------- ENDURE MALE GENITAL DESENSITIZING SPRAY ACTIVE INGREDIENT Lidocaine HCl 10mg PURPOS E Topical Anesthetic US ES : To help prevention of premature ejaculation WARNINGS • Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a physician. • Avoid contact with eyes. • If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a physician. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes. DIRECTIONS : Prior to sexual intercourse, apply 3-6 sprays to the head and the shaft of the penis, not to exceed 10 sprays, or use as directed by a physician. OTHER INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, L-Arginine, Lepidium Meyenii (Maca) Root Extract, Panax Ginseng Root Extract, Phenoxyethanol, Serenoa Serrulata (Saw Palmetto) Fruit Extract. Distributed by: ENDURE HOLDINGS LLC WWW.ENDUREHOLDINGS.COM 5602 MARQUESAS CIRCLE STE 207 SARASOTA, FL 34233 PACKAGE LABEL ENDURE Male Genital Desensitizing Spray Fast Acting Lidocaine-Based Formulation Color-Less Odor-Less Discreet WWW.ENDUREHOLDINGS.COM Net Contents: 0.25 Oz. ENDURE MALE GENITAL DESENSITIZING lidocaine hydrochloride spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 6 14-370 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH Endure Holdings, LLC LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 10 mg in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE N Read the complete document