Theracare 16% Menthol Pain Relief Spray

Theracare 16% Menthol Pain Relief Spray
SPL v1
SPL
SPL Set ID ea56e4e1-a758-428b-8758-ee31bb00ca82
Route
TOPICAL
Published
Effective Date 2026-01-05
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 2026-01-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

 for temporary relief of minor pain and associated with:

  • arthritis
  • strains
  • sprains
  • bruises

Section 42229-5

Drug Facts

Section 55105-1

Pain relieving spray

Warnings

For external use only

Flammable Do not use while smoking or near heat of flame. Do not use while smoking.  Do not punture or incinerate.  Contents under pressure.

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

glycerine, propylene glycol, SD alcohol, water

When Using This Product
  • avoid contact with eyes
  • do not apply to wounds or damage skin
  • do not bandage tightly
Principal Display Panel  

Stop Use and Ask A Doctor 
  • condition worsens
  • or if symptoms persist for more than 7 days or clear up and reoccur withing a few days.
Stop Use and Ask A Doctor If
  • condition worsens
  • or if symptoms persist for more than 7 days or clear up and reoccur 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
  • strains
  • sprains
  • bruises

Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)

Pain relieving spray

Warnings

For external use only

Flammable Do not use while smoking or near heat of flame. Do not use while smoking.  Do not punture or incinerate.  Contents under pressure.

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)

glycerine, propylene glycol, SD alcohol, water

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not apply to wounds or damage skin
  • do not bandage tightly
Principal Display Panel   (PRINCIPAL DISPLAY PANEL - )

Stop Use and Ask A Doctor  (Stop use and ask a doctor )
  • condition worsens
  • or if symptoms persist for more than 7 days or clear up and reoccur withing a few days.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • or if symptoms persist for more than 7 days or clear up and reoccur 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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