natures willow balm pain relief xl patch

natures willow balm pain relief xl patch
SPL v1
SPL
SPL Set ID 0ce13ead-fc34-b1e6-e063-6394a90a3d67
Route
topical
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salix alba bark (0.5 mg) harpagophytum procumbens root (19 mg) indian frankincense (1 mg) arnica montana flower (3 mg)
Inactive Ingredients
helichrysum italicum flower oil water dehydroacetic acid ethylhexylglycerin polysorbate 60 butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) vanillyl butyl ether benzoic acid peppermint oil glycerin camphor (natural) geranium oil, algerian type phenoxyethanol lavender oil eucalyptus oil

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2023-12-29

Purpose

Purpose* Trauma, muscle pain and stiffness

Description

Devils Claw Cut Root [Harpagophytum procumbens] **(19mg) Arnica Montana **(3mg) Boswellia Serrata Extract **(1mg) Salix Alba **(0.5mg) **This ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings

For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients in this product

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • burning, itching or excessive skin irritation occurs
  • condition worsens
  • symptoms persist for more than 3 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Uses

For the temporary relief of minor aches and pains of muscles and joints

Purpose

Purpose*

Trauma, muscle pain and stiffness

Directions

adults and children over 12 years of age:

  • clean and dry affected area
  • open pouch and remove patch. If desired, cut patch to size
  • remove transparent film from patch and apply to affected area for up to 8 hours
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a physician

Other Information
  • do not use if the packaging is broken or punctured
  • dispose of patch after single use
  • store in cool dry place
Inactive Ingredients

Benzoic Acid, Butyl Acrylate, Camphor, Dehydroacetic Acid, Ethylhexylglycerin, Eucalyptus Oil, Geranium Oil, Glycerin, Helichrysum Italicum Oil, Lavender Oil, Methyl Methacrylate, Methacrylic, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Water, Vanillyl Butyl Ether

Description

Devils Claw Cut Root [Harpagophytum procumbens] **(19mg) Arnica Montana **(3mg) Boswellia Serrata Extract **(1mg) Salix Alba **(0.5mg) **This ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Section 51945-4

Active Ingredients

Devils Claw Cut Root [Harpagophytum procumbens] **(19mg)

Arnica Montana **(3mg)

Boswellia Serrata Extract **(1mg)

Salix Alba **(0.5mg)

**This ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Questions Or Comments

1-888-609-4556

Spl Unclassified Section

*These statements or claims are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Kep Out of Reach of Children

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.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients in this product

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • burning, itching or excessive skin irritation occurs
  • condition worsens
  • symptoms persist for more than 3 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Uses (USES)

For the temporary relief of minor aches and pains of muscles and joints

Purpose

Purpose*

Trauma, muscle pain and stiffness

Directions

adults and children over 12 years of age:

  • clean and dry affected area
  • open pouch and remove patch. If desired, cut patch to size
  • remove transparent film from patch and apply to affected area for up to 8 hours
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a physician

Other Information
  • do not use if the packaging is broken or punctured
  • dispose of patch after single use
  • store in cool dry place
Inactive Ingredients

Benzoic Acid, Butyl Acrylate, Camphor, Dehydroacetic Acid, Ethylhexylglycerin, Eucalyptus Oil, Geranium Oil, Glycerin, Helichrysum Italicum Oil, Lavender Oil, Methyl Methacrylate, Methacrylic, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Water, Vanillyl Butyl Ether

Section 51945-4 (51945-4)

Active Ingredients

Devils Claw Cut Root [Harpagophytum procumbens] **(19mg)

Arnica Montana **(3mg)

Boswellia Serrata Extract **(1mg)

Salix Alba **(0.5mg)

**This ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Questions Or Comments (Questions or Comments)

1-888-609-4556

Spl Unclassified Section (SPL Unclassified Section)

*These statements or claims are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Kep Out of Reach of Children (Kep 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

All Sections (JSON)