SPL v1
SPL
SPL Set ID 3712e151-d171-1c5d-e063-6294a90a36c0
Route
TOPICAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Alcohol Carbomer 940 Aloe Vera Leaf .alpha.-tocopherol Acetate Chamomile Glycerin Propylene Glycol Cucumber Disodium Cocoamphodipropionate Water Trolamine Ascorbic Acid Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

Lidocaine 5%


Medication Information

Warnings and Precautions

For external use only.

Flammable. Keep away from excessive heat or open flame.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this into the rectum by using fingers or any mechanical device or applicator
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Indications and Usage

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration
  • When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly and gently pat dry. Spray affected area, wash hands after applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.
Description

Lidocaine 5%

Section 50565-1

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

Section 51727-6

Alcohol denat., aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration (34068-7)
  • When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly and gently pat dry. Spray affected area, wash hands after applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.
Warnings and Precautions (34071-1)

For external use only.

Flammable. Keep away from excessive heat or open flame.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this into the rectum by using fingers or any mechanical device or applicator
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Alcohol denat., aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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