Label: PLEASURE BALM KAMA SUTRA- benzocaine gel
- NDC Code(s): 56152-1470-1
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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ACTIVE INGREDIENT
Active Ingredients Purpose
Benzocaine 5.0 % Male genital desensitizer
Use
Helps in temporarily prolonging time until ejaculation
Keep out of reach of children.
Discontinue use and consult a doctor if
This product, used as directed does not provide relief
You or your partner develops a rash or irritation, such as burning or itching
Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder which may appear up to 2 hours of use
Warnings
DO NOT use if allergic to Benzocaine or any other ingredient in this product
If swallowed seek medical assistance or contact a poison control or contact a poison control Center right away.
Premature ejaculation may be due to condition requiring medical supervision
Consult a doctor prior to use if partner is pregnant
Avoid contact with eyes: if this happens, rinse thoroughly with water
Known adverse reactions Hypersensitivity/allergy has been known to occur, in such a case, discontinue use.
Directions for use
Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse. For external Use only.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLEASURE BALM KAMA SUTRA
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-1470 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE DISODIUM (UNII: 7FLD91C86K) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) MENTHA PIPERITA (UNII: 79M2M2UDA9) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) 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:56152-1470-1 12 mL in 1 TUBE; Type 0: Not a Combination Product 12/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 09/12/2013 Labeler - Cosmetic Enterprises Ltd (017701475)
