83881-001 lidopro transdermal pain relief & applicator

83881-001 lidopro transdermal pain relief & applicator
SPL v1
SPL
SPL Set ID c259ef92-5d07-4590-adf1-3a106333eee0
Route
transdermal
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, (+)- (10 mg) salicylic acid (4 mg) capsaicin (27.5 mg)
Inactive Ingredients
aloe vera leaf trolamine water matricaria chamomilla whole ammonium acryloyldimethyltaurate/vp copolymer glyceryl monostearate phenoxyethanol cetyl alcohol dimethicone, unspecified ethylhexylglycerin peg-100 monostearate allantoin edetate disodium glycerin inulin lauryl carbamate stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-21
Purpose

• counterirritant • anesthetic • analgesic

Description

• Capsicum annum fruit extract (capsaicin) • Lidocaine HCL • Menthol • Methyl Salicylate

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
  • •
    anesthetic
  • •
    analgesic
Directions

Adults and children 12 years of age and older:

  • •
    clean and dry the affected area
  • •
    apply product directly to skin, up to 4 times daily
  • •
    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
Description

• Capsicum annum fruit extract (capsaicin) • Lidocaine HCL • Menthol • Methyl Salicylate

Questions?

(800) 224-2048 or [email protected]

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8833-9

Label
Flammable

Keep away from excessive heat or open flame.

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
Active Ingredient
  • •
    Capsicum annum fruit extract (capsaicin)
  • •
    Lidocaine HCL
  • •
    Menthol
  • •
    Methyl Salicylate
Inactive Ingredient

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

When Using This Product

avoid contact with the eyes and mucous membranes

Stop Use and Ask Doctor If
  • •
    condition worsens
  • •
    excessive skin
  • •
    irritation develops
  • •
    symptoms persist for more than 7 days
  • •
    symptoms clear up and occur again within 3 days
If Pregnant Or Breast Feeding

ask a health professional before use.

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
  • •
    anesthetic
  • •
    analgesic
Directions

Adults and children 12 years of age and older:

  • •
    clean and dry the affected area
  • •
    apply product directly to skin, up to 4 times daily
  • •
    wash hands immediately after use

Children under 12 years of age: Consult physician.

Other Information (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?

(800) 224-2048 or [email protected]

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8833-9

Label
Flammable

Keep away from excessive heat or open flame.

Do Not Use (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
Active Ingredient (Active ingredient)
  • •
    Capsicum annum fruit extract (capsaicin)
  • •
    Lidocaine HCL
  • •
    Menthol
  • •
    Methyl Salicylate
Inactive Ingredient (Inactive ingredient)

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

When Using This Product (When using this product)

avoid contact with the eyes and mucous membranes

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • •
    condition worsens
  • •
    excessive skin
  • •
    irritation develops
  • •
    symptoms persist for more than 7 days
  • •
    symptoms clear up and occur again within 3 days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:36.242801 · Updated: 2026-03-14T23:07:39.601528