BOY BUTTER EXTREME H2O DESENSITIZING LUBRICANT- benzocaine cream

Boy Butter by

Drug Labeling and Warnings

Boy Butter by is a Otc medication manufactured, distributed, or labeled by Boy Butter Lubes, Creations Garden Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Benzocaine 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 in the male in advance of intercourse.
  

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.

• If this product, used as directed, does not provide relief, discontinue use and consult a physician
• Avoid contact 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 head and shaft of penis before intercourse, or use as directed by a physician.

• Wash off product after intercourse.
  

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, Diazolidyl Urea, Propylparaben Yellow 5, Fragrance.

Questions or Comments:

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

BOY BUTTER  EXTREME H2O DESENSITIZING LUBRICANT
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	4.25 g  in 85.05  g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-003-45	85.05 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/27/2011

Labeler - Boy Butter Lubes (961956229)

Registrant - Creations Garden Natural Products (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products		961956229	manufacture