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

image description
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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

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