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 Ingredient:

Benzocaine 7.5%

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

Questions or Comments:

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

Placeholder Text

BB_Extreme_9oz_label

BOY BUTTER  DESENSITIZING LUBRICANT
benzocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-043
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 71.9395789 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:24488-043-83 266 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 09/25/2012
Labeler - Boy Butter Lubes (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
Name Address ID/FEI Business Operations
Creation's Garden Natural Products 961956229 manufacture(24488-043)

Revised: 9/2012
Document Id: 975672d1-cc6d-435d-b332-2e2deb94c221
Set id: 48aeca34-2cd5-41aa-98ba-606bda1f9ce3
Version: 1
Effective Time: 20120925
 
Boy Butter Lubes