Healthwise 16% Menthol Pain Relief Spray

Healthwise 16% Menthol Pain Relief Spray
SPL v2
SPL
SPL Set ID e4bfb6b0-545e-4fbc-8538-4f41a6be1025
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Alcohol 95% Propylene Glycol Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

 for temporary relief of minor pain and associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Section 42229-5

Drug Facts

Section 55105-1

External analgesic

Warnings

For external use only

Flammable Do not use while smoking or near heat of flame.

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
Inactive Ingredients

glycerine, propylene glycol, SD alcohol, water

When Using This Product
  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not bandage tightly
  • do not use with heating pad
  • contents under pressure.  Do not punture or incinerate.  Do not store at temperature above 120 F
Principal Display Panel  

Stop Use and Ask A Doctor 
  • condition worsens
  • rash or irritation develops and lasts for more than 7 days or clear up and occur again withing a few days
Stop Use and Ask A Doctor If
  • condition worsens
  • rash or irritation develops and last for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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


Structured Label Content

Uses

 for temporary relief of minor pain and associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)

External analgesic

Warnings

For external use only

Flammable Do not use while smoking or near heat of flame.

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
Inactive Ingredients (Inactive ingredients)

glycerine, propylene glycol, SD alcohol, water

When Using This Product (When using this product)
  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not bandage tightly
  • do not use with heating pad
  • contents under pressure.  Do not punture or incinerate.  Do not store at temperature above 120 F
Principal Display Panel   (PRINCIPAL DISPLAY PANEL - )

Stop Use and Ask A Doctor  (Stop use and ask a doctor )
  • condition worsens
  • rash or irritation develops and lasts 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)
  • condition worsens
  • rash or irritation develops and last for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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