Label: EJECTDELAY GEL- benzocaine gel
- NDC Code(s): 57483-003-03, 57483-003-07, 57483-003-08
- Packager: Innovus Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Male genital desensitizerClose
Helps in the prevention of premature ejaculationClose
For external use onlyClose
- When using this product
Avoid contact with eyesClose
- Stop use and ask a doctor if
- Premature ejaculation may be due to a condition requiring medical supervision
- This product, used as directed, does not provide relief, discontinue use and consult a physician
- You or your partner develop a rash or irritation, such as burning or itching, discontinue use
- If symptoms persist, consult a doctor
- Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right awayClose
Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician.
Wash product off after intercourseClose
- Inactive Ingredients
Glycerin Natural USP Kosher, PEG 8 Pluracol E 400 NF, PEG 3350, PEG 540 Blend USP, Carbowax 4000, Sodium Saccharin Powder USP, Sorbic Acid, WaterClose
- Questions or Comments
For questions or comments please call 1-858-964-5123Close
- INGREDIENTS AND APPEARANCE
benzocaine 7.5% gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-003 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-003-07 1 in 1 BOX 1 NDC:57483-003-03 56.8 g in 1 TUBE 2 NDC:57483-003-08 5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 07/15/2013 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Registrant - Innovus Pharmaceuticals, Inc. (962507187) Establishment Name Address ID/FEI Business Operations U.S. Pharmaceuticals, Inc. 009248480 manufacture(57483-003)