Label: MANDELAY MALE GENITAL DESENSITIZER- benzocaine gel
- NDC Code(s): 10705-077-01, 10705-077-28
- Packager: Majestic Drug Co., 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.
Updated November 9, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active Ingredient
For external use only
Stop use and ask a doctor if
- this product, used as directed,does not provide relief. Premature ejaculation may be due to condition requiring medical supervision.
- you or your partner develop a rash or irritation, such as burning or itching.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
INGREDIENTS AND APPEARANCE
MANDELAY MALE GENITAL DESENSITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10705-077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 2.13 g in 28.35 g Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10705-077-01 1 in 1 BOX 10/31/1995 1 NDC:10705-077-28 28.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part348 10/31/1995 Labeler - Majestic Drug Co., INC. (001496777)