Label: PROLONG PLUS- benzocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69797-104-01 - Packager: WSM Investment LL. Topco Sales
- 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 December 19, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
- For external use only.
- Avoid contact with eyes.
- Discontinue use if you or your partner develops rash or irritation, such as burning or itching.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROLONG PLUS
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69797-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 4.2 g in 56 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) AMERICAN GINSENG (UNII: 8W75VCV53Q) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69797-104-01 56 g in 1 TUBE; Type 0: Not a Combination Product 12/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 12/19/2017 Labeler - WSM Investment LL. Topco Sales (040346439) Establishment Name Address ID/FEI Business Operations WSM Investment LLC. Topco Sales 040346439 manufacture(69797-104)