Cal EX Desensetizer Cream 59 mL

Optimum Rock Hard Cream by

Drug Labeling and Warnings

Optimum Rock Hard Cream by is a Otc medication manufactured, distributed, or labeled by Private Label Productions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OPTIMUM ROCK HARD CREAM- cream desensitizer cream 
Private Label Productions LLC

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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Cal EX Desensetizer Cream 59 mL

Active Ingredient(s)

Benzocaine.......7.5%

Purpose

Male Genital Desensitizer

Use

Helps in prevention of premature ejaculation

Warnings

Methemoglobinemia warning: Use of this product may cause
methemoglobinemia, a serious condition that must be treated promptly
because it reduces the amount of oxygen carried in blood. This can occur
even if you have use this product before. Stop use and seek immediate
medical attention if you or a child in your care develops: ¢ pale, gray, or
blue colored skin (cyanosis) * headache e rapid heart rate ¢ shortness
of breath e dizziness or lightheadedness e fatigue or lack of energy
Allergy alert: Do not use this product if you have a history of allergy to
local anesthetics such as procaine, butacaine, benzocaine or any other
‘caine’ anesthetics.

For external use only. Avoid contact with eyes. If you or your partner
develop a rash or irritation such as burning or itching discontinue use.
Premature ejaculation may be due to a condition requiring medical
supervision. Keep out of reach of children. If symptoms persist consult a
physician. If this product, used as directed, does not provide relief,
discontinue use and consult a doctor.

Do Not Use « For teething @ In children under 2 years of age

Keep out of reach of children.

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. Children under 2 years of age: Do not use.

Other information

Store at 20-25°C ( equals 68-77°F)

Inactive ingredients

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propanediol, Propylene Glycol, Propylparaben, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

59 mL NDC: 77632-126-01

OPTIMUM ROCK HARD CREAM 
cream desensitizer cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77632-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPANEDIOL (UNII: 5965N8W85T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77632-126-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/31/2023

Labeler - Private Label Productions LLC (046278265)

Revised: 7/2023

Document Id: fff2c971-2fe4-1f6e-e053-6394a90a90c4

34390-5

Set id: fff2c946-f4c8-5633-e053-6294a90aace4

Version: 1

Effective Time: 20230708