BOY BUTTER 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 Ingredients

Benzocaine 7.5%

Purpose

Male genital desensitizer

Indications


Keep out of reach of children

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Warnings

Premature ejaculation may be due to a condition requiring medical supervision.

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician

Inactive Ingredients

Water, Petrolatum, Propylene Glycol, Cyclopentasiloxane, Mineral Oil, Glyceryl Stearate Se, Polysorbate 60, Glycol 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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BOY BUTTER  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) BENZOCAINE6.39 g  in 85.2 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:24488-003-4085.2 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: b7e1fc03-6123-404b-ad83-03e6e144f0b6
Set id: c8e6a948-e863-4322-9dd5-814c8d1995eb
Version: 1
Effective Time: 20110523
 
Boy Butter Lubes