healthwise maximum otc strength lidocaine pain relief

healthwise maximum otc strength lidocaine pain relief
SPL v5
SPL
SPL Set ID afc3c16d-0076-44b2-ae7e-5f36d4d8088e
Route
topical
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
alcohol 95% propylene glycol caprylic/capric triglyceride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-01

Description

Drug Facts


Medication Information

Warnings

For external use only

Flammable Keep away from fire or flame. Do not use while smoking.  Do not punture or incinerate.  Contents under pressure.

Uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak or poison sumac
Directions
  • adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily.  
  • children under 2 years of age:do not use, ask a doctor
Other Information
  • Store out of direct sunlight, in a cool dry well-ventilated area
  • Do not store at temperature above 120F (49C)
Inactive Ingredients

caprylic/capric triglyceride, propylene glycol, SD alcohol

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 55105-1

Pain relieving spray

When Using This Product
  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Principal Display Panel  

Stop Use and Ask A Doctor 
  • skin irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again withing a few days
Stop Use and Ask A Doctor If
  • skin irritation develops
  • condition worsens, or symptoms persist for more than 7 days symptoms or clear up and occur again within a few days

Structured Label Content

Warnings

For external use only

Flammable Keep away from fire or flame. Do not use while smoking.  Do not punture or incinerate.  Contents under pressure.

Uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak or poison sumac
Directions
  • adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily.  
  • children under 2 years of age:do not use, ask a doctor
Other Information (Other information)
  • Store out of direct sunlight, in a cool dry well-ventilated area
  • Do not store at temperature above 120F (49C)
Inactive Ingredients (Inactive ingredients)

caprylic/capric triglyceride, propylene glycol, SD alcohol

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 55105-1 (55105-1)

Pain relieving spray

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Principal Display Panel   (PRINCIPAL DISPLAY PANEL - )

Stop Use and Ask A Doctor  (Stop use and ask a doctor )
  • skin irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again withing a few days
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin irritation develops
  • condition worsens, or symptoms persist for more than 7 days symptoms or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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