lidopro 4% ointment

lidopro 4% ointment
SPL v3
SPL
SPL Set ID 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd
Route
topical
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.000325 g) menthol (0.04 g) salicylic acid (0.1 g)
Inactive Ingredients
inulin stearic acid allantoin aloe vera leaf ammonium acryloyldimethyltaurate/vp copolymer cetyl alcohol chamomile dimethicone, unspecified edetate disodium ethylhexylglycerin glycerin glyceryl monostearate peg-100 monostearate trolamine water phenoxyethanol

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2022-07-08

Purpose

Counterirritant

Description

Capsaicin 0.0325%


Medication Information

Warnings

For External Use Only

Uses

For the temporary relief of joint pain and muscle pain associated with:

  • Arthritis
  • Simple Backache
  • Muscle Sprains
  • Muscle Strains
Purpose

Counterirritant

Directions

Adults and Children 12 Years of Age and Older:

  • Clean and dry the affected area
  • Apply product directly to your skin, up to 4 times daily affected area
  • Wash hands immediately after use

Children Under 12 Years of Age: Consult physician

Other Information
  • Store in a cool, dry place with lid tightly closed
  • If the tamper-evident foil seal is not intact, do not use
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Description

Capsaicin 0.0325%

Principal Display Panel

NDC 53225-1020-1

Preferred Pharmaceuticals Inc. NDC 68788-8314-1

Do Not Use
  • On damaged, irritated, or infected skin

  • With a bandage or heating pad

  • If you are allergic to any ingredients in this product
Flammable:

Keep away from excessive heat or open flame

Active Ingredient

Capsaicin 0.0325%

Questions Or Comments?

[email protected]

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product:

Avoid contact with eyes and mucus membranes

If Pregnant Orbreast Feeding:

Ask a health professional before use.

Stop Use and Ask A Doctor If:
  • Conditions worsens
  • Excessive skin irritation develops
  • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days
Keep Out of Reach of Children:

If ingested seek medical help or contact a Poison Control Center immediately


Structured Label Content

Warnings

For External Use Only

Uses

For the temporary relief of joint pain and muscle pain associated with:

  • Arthritis
  • Simple Backache
  • Muscle Sprains
  • Muscle Strains
Purpose

Counterirritant

Directions

Adults and Children 12 Years of Age and Older:

  • Clean and dry the affected area
  • Apply product directly to your skin, up to 4 times daily affected area
  • Wash hands immediately after use

Children Under 12 Years of Age: Consult physician

Other Information
  • Store in a cool, dry place with lid tightly closed
  • If the tamper-evident foil seal is not intact, do not use
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Principal Display Panel

NDC 53225-1020-1

Preferred Pharmaceuticals Inc. NDC 68788-8314-1

Do Not Use
  • On damaged, irritated, or infected skin

  • With a bandage or heating pad

  • If you are allergic to any ingredients in this product
Flammable:

Keep away from excessive heat or open flame

Active Ingredient

Capsaicin 0.0325%

Questions Or Comments? (Questions or Comments?)

[email protected]

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product:

Avoid contact with eyes and mucus membranes

If Pregnant Orbreast Feeding: (If Pregnant orBreast-Feeding:)

Ask a health professional before use.

Stop Use and Ask A Doctor If: (Stop Use and Ask a Doctor If:)
  • Conditions worsens
  • Excessive skin irritation develops
  • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days
Keep Out of Reach of Children:

If ingested seek medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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