JO for Him Prolonger with Lidocaine by CC Wellness LLC / CC Wellness, LLC

JO for Him Prolonger with Lidocaine by

Drug Labeling and Warnings

JO for Him Prolonger with Lidocaine by is a Otc medication manufactured, distributed, or labeled by CC Wellness LLC, CC Wellness, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JO FOR HIM PROLONGER WITH LIDOCAINE- lidocaine 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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Active Ingredients:

Lidocaine 10%

Purpose:

Male Genital Desensitizer

Uses:

• Helps in the prevention of premature ejaculation
• Helps in temporarily prologing the time until ejaculation

Warnings:

For External Use Only

Avoid contact with the eye

Allergy Alert: do not use this product if you or your partner are allergic (sensitive) to local anesthetis or any other 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 a 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 the usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.

Keep out of reach of children

Directions:

Use only as directed

Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or use as directed by a doctor.

Wash product off after intercourse

Other information:

Storeage instructions: Store below 86 F (30 C)

Inactive ingredients:

Water (Aqua), Glycerin, SD Alcohol 40 B, Phenoxyethanol, Red 40

JO FOR HIM PROLONGER WITH LIDOCAINE 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71683-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71683-001-01	1 in 1 BOX	09/22/2015
1	NDC: 71683-001-02	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 not final	part348	09/22/2015

Labeler - CC Wellness LLC (067692292)

Establishment
Name	Address	ID/FEI	Business Operations
CC Wellness, LLC		067692292	manufacture(71683-001)

Revised: 5/2022

Document Id: de5a5ee4-5dfa-e38d-e053-2995a90ab94a

34390-5

Set id: b12dc6a3-142d-3219-e053-2995a90aead0

Version: 2

Effective Time: 20220506