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

Warnings

For external use only

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

Uses

 for temporary relief of minor pain and associated with:

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

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 55105-1

External analgesic

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

Warnings

For external use only

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

Uses

 for temporary relief of minor pain and associated with:

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

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

Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)

External analgesic

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

All Sections (JSON)