DZEUS Climax Control Wipes: Package Insert and Label Information

DZEUS CLIMAX CONTROL WIPES- benzocaine cloth
Sambria Pharmaceuticals, 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.

Active ingredient

Benzocaine USP 7%

Purpose

Male genital desensitizer

Uses

• Aids in the prevention of premature ejaculation
• Aids in temporarily prolonging the time until ejaculation

Warnings

For External Use only.
Do not use on broken or inflamed skin.
If pregnant or breastfeeding , ask a health professional before use.
When using this product, avoid contact with eyes.
Stop and ask doctor if:
This product, when used as directed, does not provide relief; premature ejaculation may be due to a condition requiring medical supervision,you or your partner develop rash or irritation, such as burning or itching symptoms persist.

Keep out of reach of children

In case of ingestion, seek professional assistance and contact poison control immediately.

Directions

Use wipe to apply a small amount of product to the head and shape of the penis before intercourse, or as directed by a doctor. Wash off after intercourse.
Allow product to dry prior to intercourse.
Not suitable for oral use.
Use as directed.

Other information

Store between 20°-25 °C (68°-77 °F)

Inactive ingredients

Lactic Acid, Phenol, Phenoxyethanol, ethylhexylglycerin, Polyethylene Glycol, purified water

Product label

DZEUS CLIMAX CONTROL WIPES benzocaine cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-006 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 7 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER LACTIC ACID, UNSPECIFIED FORM PHENOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54723-006-01 3 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/08/2021

Labeler — Sambria Pharmaceuticals, LLC (078676259)

Revised: 12/2022 Sambria Pharmaceuticals, LLC