Label: PROLONG- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70742-089-01 - Packager: Product Max Group 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 August 7, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive Ingredient
- Purpose
- Keep out of reach of children
- Uses
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Warnings
For external use only.
- Avoid contact with the eyes.
- 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.
- Directions
- Other Information
- Inactive Ingredients
- PROLONG product label
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INGREDIENTS AND APPEARANCE
PROLONG
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70742-089 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 2833 mg in 60 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70742-089-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 06/15/2016 Labeler - Product Max Group Inc (134893911) Registrant - Product Max Group Inc (134893911)