body action products: butt eze benzocaine gel

body action products: butt eze benzocaine gel
SPL v2
SPL
SPL Set ID ba75b129-7939-4373-91f5-1772976e6d61
Route
topical
Published
Effective Date 2022-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (50 mg)
Inactive Ingredients
cannabis sativa seed oil hydroxyethyl cellulose, unspecified methylparaben polyethylene glycol 400 polysorbate 20 propylene glycol propylparaben water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-04-29

Purpose

Anorectal (Hemorrhoidal) Gel

Description

Benzocaine 5%


Medication Information

Warnings

For external use only.

  • Avoid contact with the eyes.
  • Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
Uses
  • For temporary relief of pain or soreness in the perianal area.
Purpose

Anorectal (Hemorrhoidal) Gel

Directions
  • When practial, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Apply to the affected area up to 6 times daily.
Other Information

Do not use if safety seal is broken or missing.

Inactive Ingredients

Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Methylparaben, PEG-8, Polysorbate 20, Propylene Glycol, Propylparaben, Water.

Description

Benzocaine 5%

Active Ingredient

Benzocaine 5%

Package Labeling:

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.

  • Avoid contact with the eyes.
  • Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
Uses
  • For temporary relief of pain or soreness in the perianal area.
Purpose

Anorectal (Hemorrhoidal) Gel

Directions
  • When practial, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Apply to the affected area up to 6 times daily.
Other Information

Do not use if safety seal is broken or missing.

Inactive Ingredients

Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Methylparaben, PEG-8, Polysorbate 20, Propylene Glycol, Propylparaben, Water.

Active Ingredient

Benzocaine 5%

Package Labeling:

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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