Desensitizing cream by I Shay Cosmetics Inc Desensitizing Cream

Desensitizing cream by

Drug Labeling and Warnings

Desensitizing cream by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESENSITIZING CREAM- desensitizing cream lotion 
I Shay Cosmetics Inc

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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Desensitizing Cream

Benzocaine 5% .... Male Genital Desensitizer

Male Genital Desensitizer

WARNINGS - Keep out of reach of children

For temporary male genital desensitization, helping to slow the onset of ejaculation.

Deionized Water, Propylene Glycol, Coconut Oil, Stearic Acid, Isopropyl Palmitate, Capric/Caprylic Triglyceride, Soya Oil, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20 Glycol Stearate, Dimethicone 100, PEG-100, Sodium Hydroxide, Carbomer, Phenoxyethanol, Propylparaben, Methylparaben, Fragrance.

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.

Keep out of reach of children.

If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor. Avoid contact with the eyes.

DIRECTIONS

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.

DESENSITIZING CREAM 
desensitizing cream lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.8 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-209-01	142 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/25/2006	12/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	06/25/2006	12/07/2022

Labeler - I Shay Cosmetics Inc (151582384)

Revised: 10/2022

Document Id: ea7aa07c-5a3e-d16b-e053-2a95a90a9d9f

34390-5

Set id: b9e48f11-a6f8-4de4-e053-2a95a90a81ee

Version: 3

Effective Time: 20221007