BOY BUTTER EXTREME H2O 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 5%

Purpose:

Male genital desensitizer

Indications:

Helps in the prevention of premature ejaculation.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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, Cyclopentasiloxane, Propylene Glycol, Glyceryl Stearate and PEG-100 Stearate, Paraffinum Liquidum (Mineral Oil), Butyrospermum Parkii (Shea Butter), Tricaprylin, Cocos Nucifera (Coconut) Oil, Glycerin, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Methylparaben, Diazolidinyl Urea, Propylparaben, Yellow 5, Fragrance

Questions or Comments:

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

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BOY BUTTER  EXTREME H2O 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)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
MINERAL OIL (UNII: T5L8T28FGP)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRICAPRYLIN (UNII: 6P92858988)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-003-70454 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/27/2011
Labeler - Boy Butter Lubes (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creation's Garden Natural Products961956229manufacture

Revised: 6/2011
Document Id: 65541c40-dd2b-414d-b60b-a8908d3261f5
Set id: 5d40a53c-6066-4729-8db8-08307f39bcd9
Version: 1
Effective Time: 20110627
 
Boy Butter Lubes