3712e151-d171-1c5d-e063-6294a90a36c0

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
Active Ingredient

Lidocaine 5%

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


Structured Label Content

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
Active Ingredient (55106-9)

Lidocaine 5%

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.
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


Advanced Ingredient Data


Raw Label Data

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