Label: EJECTDELAY GEL- benzocaine 7.5% gel
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Contains inactivated NDC Code(s)
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
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.
Drug Label Information
Updated November 6, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Indications
- Warnings
- SPL UNCLASSIFIED SECTION
- When using this product
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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
- Directions
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EJECTDELAY GEL
benzocaine 7.5% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-003 Route of Administration TOPICAL 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)