Pramoxine Hcl 1% Lotion

Pramoxine Hcl 1% Lotion
SPL v3
SPL
SPL Set ID dc646399-91ba-5cc1-e053-2a95a90a4f9c
Route
TOPICAL
Published
Effective Date 2022-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Cetyl Alcohol Glycerin Petrolatum Stearyl Alcohol Mineral Oil Water Phenoxyethanol Glyceryl Stearate Se Xanthan Gum Peg-100 Stearate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-11
Description

pramoxine HCl 1% w/w

Purpose

local anesthetic

Medication Information

Purpose

local anesthetic

Description

pramoxine HCl 1% w/w

Use

for the temporary relief of discomfort and itch in the perianal area

Do Not
  • exceed the recommended daily dosage unless directed by a doctor
  • put this product into the rectum by using fingers or any mechanical device or applicator



Warnings

For external use only.

Directions
  • Shake well before use.
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
  • Children under 12 years of age: consult a doctor.



Package Label

Questions or comments call 1-855-361-3993.

Manufactured for:

AvKARE

Pulaski, TN 38478

www.avkare.com

AV 01/2022

Active Ingredient

pramoxine HCl 1% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms do not improve within 7 days
  • allergic reactions develop to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase

Keep Out of Reach of Children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Structured Label Content

Use

for the temporary relief of discomfort and itch in the perianal area

Do Not (Do not)
  • exceed the recommended daily dosage unless directed by a doctor
  • put this product into the rectum by using fingers or any mechanical device or applicator



Purpose

local anesthetic

Warnings

For external use only.

Directions
  • Shake well before use.
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
  • Children under 12 years of age: consult a doctor.



Package Label

Questions or comments call 1-855-361-3993.

Manufactured for:

AvKARE

Pulaski, TN 38478

www.avkare.com

AV 01/2022

Active Ingredient

pramoxine HCl 1% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms do not improve within 7 days
  • allergic reactions develop to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek medical attention or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.928445 · Updated: 2026-03-14T23:02:37.591705