medfreeze naturally cool pain relief spray

medfreeze naturally cool pain relief spray
SPL v2
SPL
SPL Set ID 240f2346-c585-4334-997c-45db6268d7c4
Route
topical
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (120 mg)
Inactive Ingredients
water calendula officinalis flower green tea leaf chamomile citric acid monohydrate echinacea angustifolia whole glycerin ilex paraguariensis leaf dimethyl sulfone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-20

Purpose

Cooling pain relief

Description

Menthol 12%


Medication Information

Warnings
  • For external use only
  • Flammable 
  • Keep away from excessive heat or open flame 
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)
Uses

Temporary relief of minor aches and pains of muscles and joints associated with:  Simple, backache, arthritis, strains, sprains.

Purpose

Cooling pain relief

Other Information
  • Replace cap after use 
  • Store in a cool, dry place
Description

Menthol 12%

Questions?

Call 786-956-7146

Do Not Use
  • With heating pad or device 
  • With ointments, creams, sprays or liniments 
  • On wounds, damaged skin or irritated skin
Ingredients

Aqua (deionized water), Calendula officinalis extract, Camellia Sinensis (green tea) extract, Chamomilla Matricaria (chamomile) extract, Citric acid, Echinacea angustifolia extract, Glycerin, Ilex Paraguariensis (Yerba Mate) extract, Berry extract of Juniperus Communis (juniper), Methylsulfonylmethane (MSM), SD-Alcohol 40B.

Instructions

Adults / Children 2 years and older:

  • Spray on the affected area not more than 3 to 4 times daily 
  • Shake well before use

Children under 2 years old:Consult a physician.

Package Labeling:

Active Ingredients

Menthol 12%

When Using This Product
  • Avoid contact with eyes or mucous membranes 
  • Do not bandage tightly
Stop Use and Ask A Doctor If
  • Condition worsens 
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days  
  • Irritation develops
Ask A Doctor Before Use If You
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings
  • For external use only
  • Flammable 
  • Keep away from excessive heat or open flame 
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)
Uses

Temporary relief of minor aches and pains of muscles and joints associated with:  Simple, backache, arthritis, strains, sprains.

Purpose

Cooling pain relief

Other Information (Other information)
  • Replace cap after use 
  • Store in a cool, dry place
Questions?

Call 786-956-7146

Do Not Use (Do not use)
  • With heating pad or device 
  • With ointments, creams, sprays or liniments 
  • On wounds, damaged skin or irritated skin
Ingredients

Aqua (deionized water), Calendula officinalis extract, Camellia Sinensis (green tea) extract, Chamomilla Matricaria (chamomile) extract, Citric acid, Echinacea angustifolia extract, Glycerin, Ilex Paraguariensis (Yerba Mate) extract, Berry extract of Juniperus Communis (juniper), Methylsulfonylmethane (MSM), SD-Alcohol 40B.

Instructions

Adults / Children 2 years and older:

  • Spray on the affected area not more than 3 to 4 times daily 
  • Shake well before use

Children under 2 years old:Consult a physician.

Package Labeling:

Active Ingredients (Active ingredients)

Menthol 12%

When Using This Product (When using this product)
  • Avoid contact with eyes or mucous membranes 
  • Do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens 
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days  
  • Irritation develops
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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