playmakar roll-on cool pain relief gel

playmakar roll-on cool pain relief gel
SPL v4
SPL
SPL Set ID a12c16e7-561f-45a7-93c6-34d693ffdc7c
Route
topical
Published
Effective Date 2023-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (60 mg)
Inactive Ingredients
aloe vera leaf water arctium lappa root arnica montana calendula officinalis flower green tea leaf carboxypolymethylene ethylhexylglycerin glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis phenoxyethanol polysorbate 20 .alpha.-tocopherol acetate, d- trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-20

Description

Menthol 6%


Medication Information

Warnings

For external use only

  • Avoid contact with eyes
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
  • Children under two-years of age: consult a physician
Other Information

store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

Description

Menthol 6%

Section 55105-1

Topical Analgesic

Drug Facts

Do Not Apply
  • to wounds or damaged skin
  • Do not bandage tightly
Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.

Active Ingredient

Menthol 6%

Package Labeling:

If Pregnant Or Breast Feeding

contact physician prior to use

Keep Out of Reach of Children

If swallowed, consult physician


Structured Label Content

Warnings

For external use only

  • Avoid contact with eyes
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
  • Children under two-years of age: consult a physician
Other Information (Other information)

store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

Section 55105-1 (55105-1)

Topical Analgesic

Drug Facts

Do Not Apply (Do not apply)
  • to wounds or damaged skin
  • Do not bandage tightly
Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.

Active Ingredient (Active ingredient)

Menthol 6%

Package Labeling:

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

contact physician prior to use

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, consult physician


Advanced Ingredient Data


Raw Label Data

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