drug facts

drug facts
SPL v7
SPL
SPL Set ID 61874e60-14d6-49c4-ac29-a13bc74f216c
Route
topical
Published
Effective Date 2013-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (7.5 g)
Inactive Ingredients
glycerin polyethylene glycol 400 polyethylene glycol 3350 polyethylene glycol 4000 saccharin sodium sorbic acid water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-07-15

Purpose

Male genital desensitizer

Description

Benzocaine 7.5%


Medication Information

Warnings

For external use only

Purpose

Male genital desensitizer

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician.

Wash product off after intercourse

Inactive Ingredients

Glycerin Natural USP Kosher, PEG 8 Pluracol E 400 NF, PEG 3350, PEG 540 Blend USP, Carbowax 4000, Sodium Saccharin Powder USP, Sorbic Acid, Water

Description

Benzocaine 7.5%

Section 51945-4

Indications

Helps in the prevention of premature ejaculation

Active Ingredients

Benzocaine 7.5%

Questions Or Comments

For questions or comments please call 1-858-964-5123

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor If
  • Premature ejaculation may be due to a condition requiring medical supervision
  • This product, used as directed, does not provide relief, discontinue use and consult a physician
  • You or your partner develop a rash or irritation, such as burning or itching, discontinue use
  • If symptoms persist, consult a doctor
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Warnings

For external use only

Purpose

Male genital desensitizer

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician.

Wash product off after intercourse

Inactive Ingredients

Glycerin Natural USP Kosher, PEG 8 Pluracol E 400 NF, PEG 3350, PEG 540 Blend USP, Carbowax 4000, Sodium Saccharin Powder USP, Sorbic Acid, Water

Section 51945-4 (51945-4)

Indications

Helps in the prevention of premature ejaculation

Active Ingredients

Benzocaine 7.5%

Questions Or Comments (Questions or Comments)

For questions or comments please call 1-858-964-5123

When Using This Product (When using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Premature ejaculation may be due to a condition requiring medical supervision
  • This product, used as directed, does not provide relief, discontinue use and consult a physician
  • You or your partner develop a rash or irritation, such as burning or itching, discontinue use
  • If symptoms persist, consult a doctor
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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