Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 454c3458-7e40-0e5e-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2012-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.05 g) Benzalkonium (0.0013 g)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Water Glyceryl Monostearate Isopropyl Palmitate Isopropyl Stearate Lanolin Alcohols Methylparaben Mineral Oil Peg-100 Stearate Propylparaben .alpha.-tocopherol Acetate Trolamine Trisodium Hedta Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2005-05-01

Description

Active Ingredients Benzocaine 5% Benzalkonium Chloride 0.13%

Purpose

Topical Analgesic First Aid Antiseptic


Medication Information

Purpose

Topical Analgesic

First Aid Antiseptic

Dosage and Administration
  • Adults and children 2 years and over: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years: Do not use-consult a doctor.
Description

Active Ingredients Benzocaine 5% Benzalkonium Chloride 0.13%

Uses

First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

  • Itching
  • Burning
  • Irritation
  • Skin infections

Section 50567-7
  • Apply to the affected area.
  • Because the area may already be irritated you could experience a slight burning sensation. If this persists more than a few minutes, remove cream and discontinue use.
  • Wash hand thoroughly with soap and water before and after use.
Section 51727-6

Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

Section 51945-4

Section 55106-9


Active Ingredients

Benzocaine 5%

Benzalkonium Chloride 0.13%

Section 60561-8

Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

Warnings

For external use only.

Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

Questions Or Comments

1-800-635-3696

When Using This Product
  • Wash hand thoroughly with soap and water before and after use
  • Avoid contact with eyes.
  • If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
  • Do not use more than 1 week unless directed by a doctor

Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
  • side effect occur. You may report sude effect to FDA at 1-800-FDA-1088
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. If in eyes, flush with water for 15 minutes and call a physician.


Structured Label Content

Uses

First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

  • Itching
  • Burning
  • Irritation
  • Skin infections

Dosage and Administration (34068-7)
  • Adults and children 2 years and over: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years: Do not use-consult a doctor.
Section 50567-7 (50567-7)
  • Apply to the affected area.
  • Because the area may already be irritated you could experience a slight burning sensation. If this persists more than a few minutes, remove cream and discontinue use.
  • Wash hand thoroughly with soap and water before and after use.
Section 51727-6 (51727-6)

Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)


Active Ingredients

Benzocaine 5%

Benzalkonium Chloride 0.13%

Section 60561-8 (60561-8)

Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

Purpose

Topical Analgesic

First Aid Antiseptic

Warnings

For external use only.

Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

Questions Or Comments (Questions or Comments)

1-800-635-3696

When Using This Product (When using this product)
  • Wash hand thoroughly with soap and water before and after use
  • Avoid contact with eyes.
  • If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
  • Do not use more than 1 week unless directed by a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
  • side effect occur. You may report sude effect to FDA at 1-800-FDA-1088
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately. If in eyes, flush with water for 15 minutes and call a physician.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)