LubeLife Climax Control Delay by CC Wellness LLC

LubeLife Climax Control Delay by

Drug Labeling and Warnings

LubeLife Climax Control Delay by is a Otc medication manufactured, distributed, or labeled by CC Wellness LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUBELIFE CLIMAX CONTROL DELAY- benzocaine spray 
CC Wellness 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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Benzocaine 7.5%

Male Genital Desensitizer

Uses:

• For temporary male genital desensitization
• Helps to slow the onset of ejaculation

For external use only

Avoid contact with the eyes

Allergy alert: do not use this product if you are allergic (sensitive) to local anesthetics or any of the other listed ingredients

Do not use on broken or inflamed skin

Ask a doctor before use:

• If your partner is pregnant
• If you have or have had liver or kidney problems

Ask a doctor or pharmacist before use if you are already taking prescribed drugs

When using this product

• Do not get into eyes or nostrils
• Do not inhale
• Do not exceed a maximum of 20 sprays in 24 hours
• Always use the minimum amount effective for you
• Allow 5-15 minutes to dry prior to intercourse

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

Can be used for sexual intercourse and sex play when applied in accordance with usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.

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

Other information:

• Do not expose to heat or flame
• Store at 20-30°C (68-77°F)

Inactive Ingredients:

PEG-8, Propylene Glycol, Water (Aqua)

Principal Display Panel

LUBELIFE CLIMAX CONTROL DELAY 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71683-005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71683-005-01	1 in 1 BOX	01/01/2022
1	NDC: 71683-005-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/01/2022

Labeler - CC Wellness LLC (067692292)

Establishment
Name	Address	ID/FEI	Business Operations
CC Wellness LLC		067692292	manufacture(71683-005)

Revised: 6/2022

Document Id: e1a98e6d-0c25-75b8-e053-2a95a90ad136

34390-5

Set id: e1a98e6d-0c24-75b8-e053-2a95a90ad136

Version: 1

Effective Time: 20220617