BOY BUTTER EXTREME DESENSITIZING LUBRICANT- benzocaine cream 
Boy Butter Lubes

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.

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Drug Facts:

Active Ingredient:

Benzocaine 7.5%

Purpose:

Male genital desensitizer

Indications:

Helps in the prevention of premature ejaculation. For temporary male genital desensitization, helping to slow the onset of ejaculation, Helps in temporarily slowing the onset of ejaculation. For reducing oversensitivity i the male in advance of intercourse.

Keep out of reach of children

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Warnings:

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 physician. Avoid contract with the eyes. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a physician.

Directions:

Apply a small amount to the head and shaft of the penis before  intercourse, or use as directed by a physician. Wash product off after intercourse.

Inactive Ingredients:

Water, Petrolatum, Propylene Glycol, Cyclopentasiloxane, Mineral Oil, Glyceryl Stearate Se, Polysorbate 60, Glyceryl Distearate, Glycerin, Coconut Oil, Germall 11, Methylparaben, Propylparaben, Yellow 5

Questions or Comments:

For questions or comments, please call 1-818-888-6825

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BB_Extreme_16oz_label

BOY BUTTER  EXTREME DESENSITIZING LUBRICANT
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE34.05 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-003-16454 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/23/2011
Labeler - Boy Butter Lubes (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creation's Garden Natural Products961956229manufacture

Revised: 5/2011
Document Id: 74fda1b5-5bd6-4930-a283-315ca5ab791d
Set id: c36c546d-bc0c-41f8-ab3d-f5acd6a02d1e
Version: 1
Effective Time: 20110523
 
Boy Butter Lubes