Label: PLEASURE BALM KAMA SUTRA- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75956-147-01 - 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 January 15, 2015
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- Official Label (Printer Friendly)
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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. If swallowed, seek medical assistance or contact a Poison Control Center immediately.
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
Warnings
For external use only
Do not useif allergic to Benzocaine or any other ingredient in this product
Safe to use only with latex condoms only
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.
- 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:75956-147 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:75956-147-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 09/12/2013 Labeler - Kama Sutra (053877858) Registrant - Kama Sutra (053877858) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprise 017701475 manufacture(75956-147)
