Lidopro Ointment

Lidopro Ointment
SPL v2
SPL
SPL Set ID fc5f831c-169f-de28-e053-6394a90a8f1f
Route
TOPICAL
Published
Effective Date 2023-05-18
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 Edetate Disodium Ethylhexylglycerin Glycerin Glyceryl Monostearate Peg-100 Stearate Trolamine Water Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-18

Description

Capsaicin 0.0325%

Purpose

Counterirritant


Medication Information

Purpose

Counterirritant

Dosage Forms and Strengths

LidoPro Oinment is supplied as follows:

Ointent Tube of 92g NDC: 80425-0332-01

Description

Capsaicin 0.0325%

Uses

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

  • Arthritis
  • Simple Backache
  • Muscle Sprains
  • Muscle Strains
Warnings

For External Use Only

Directions

Ad ults 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

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

Inactive I

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.

If Pregnant Or

Ask a health professional before use.

Active Ingredient

Capsaicin 0.0325%

Other Information
  • Store in a cool, dry place with lid tightly closed
  • If the tamper-evident foil seal is not intact, do not use
Questions Or Comments?
Principal Display Panel

When Using This Product:

Avoid contact with eyes and mucus membranes

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

Uses

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

  • Arthritis
  • Simple Backache
  • Muscle Sprains
  • Muscle Strains
Dosage Forms and Strengths (34069-5)

LidoPro Oinment is supplied as follows:

Ointent Tube of 92g NDC: 80425-0332-01

Purpose

Counterirritant

Warnings

For External Use Only

Directions

Ad ults 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

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

Inactive I

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.

If Pregnant Or (If Pregnant or)

Ask a health professional before use.

Active Ingredient

Capsaicin 0.0325%

Other Information
  • Store in a cool, dry place with lid tightly closed
  • If the tamper-evident foil seal is not intact, do not use
Questions Or Comments? (Questions or Comments?)
Principal Display Panel

When Using This Product:

Avoid contact with eyes and mucus membranes

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

All Sections (JSON)