Label: PREBOOST- benzocaine liquid
- NDC Code(s): 69681-432-10
- Packager: The Female Health Company d/b/a Veru Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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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 doctor.
- Avoid contact with the eyes.
- If you or your partner develops a rash or irritation, such as burning or itching, discontinue use.
- If symptoms persist, consult a doctor.
- Directions
- Inactives
- PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box
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INGREDIENTS AND APPEARANCE
PREBOOST
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69681-432 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 4 g in 100 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) water (UNII: 059QF0KO0R) propylene glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69681-432-10 10 in 1 BOX 04/05/2017 1 1.2 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/30/2015 Labeler - The Female Health Company d/b/a Veru Healthcare (055300578) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(69681-432)