BOY BUTTER EXTREME 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, Creation's Garden Natural Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

BOY BUTTER  EXTREME 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	34.05 g  in 454 g

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: 24488-003-16	454 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	05/23/2011

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