Label: JO PROLONGER WITH BENZOCAINE- benzocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71683-004-01, 71683-004-02 - Packager: CC Wellness LLC
- 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 March 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- For external use only
- Ask a doctor or pharmacist before use if you are already taking prescribed drugs
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When using this product
- Do not get into eyes or nostrils
- Do not inhale
- Do not exceed a maximum of 20 sprays in 24 hours
- Always use the minimum amount effective for you
- Allow 5-15 minutes to dry prior to intercourse
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 doctor. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
Can be used for sexcual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.
- Keep out of reach of children
- Directions:
- Other information:
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JO PROLONGER WITH BENZOCAINE
benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71683-004 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71683-004-01 1 in 1 BOX 09/03/2015 1 NDC:71683-004-02 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/03/2015 Labeler - CC Wellness LLC (067692292) Establishment Name Address ID/FEI Business Operations CC Wellness LLC 067692292 manufacture(71683-004)