Label: MALE DESENSITIZER PLEASURE BALM- benzocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 75956-145-01, 75956-145-02 - Packager: Kama Sutra
- 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 July 31, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredients Purpose
Benzocaine 3.0% Male genital Desensitizer
Keep out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center
Discontinue use and consult a doctor if
This product used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.
You or your partner develop a rash or irritation, such as burning or itching.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MALE DESENSITIZER PLEASURE BALM
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75956-145 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 3.00 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75956-145-02 1 in 1 BOX 1 NDC:75956-145-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 02/14/2011 Labeler - Kama Sutra (053877858) Registrant - Kama Sutra (053877858) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprise 017701475 manufacture(75956-145)