Label: PREBOOST- benzocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62192-8500-1 - Packager: 944 Corp
- Category: HUMAN OTC DRUG LABEL
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 February 18, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- 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 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
- Inactives
- PRINCIPAL DISPLAY PANEL – pouch label
- PRINCIPAL DISPLAY PANEL – box label
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INGREDIENTS AND APPEARANCE
PREBOOST
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62192-8500 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:62192-8500-1 10 in 1 BOX 1 1.2 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 02/18/2014 Labeler - 944 Corp (054365072) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(62192-8500)