Activmend

Activmend
SPL v4
SPL
SPL Set ID baefc5d4-a7e4-4ba2-e053-2995a90a4b86
Route
TOPICAL
Published
Effective Date 2021-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypericum Perforatum (1 [hp_M]) Toxicodendron Pubescens Leaf (2 [hp_C]) Sodium Cation Ledum Palustre Twig Arnica Montana Ruta Graveolens Flowering Top
Inactive Ingredients
Alcohol Dihydroxyaluminum Aminoacetate 1,2-hexanediol Edetate Disodium Water Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Tartaric Acid Sodium Polyacrylate (8000 Mw) Carboxymethylcellulose Sodium Glycerin Titanium Dioxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-02-09

Description

Arnica Montana 1M HPUS, 10.8% Hypericum Perforatum 1M HPUS, 10.8% Ledum Palustre 1M HPUS, 10.8% Rhus Toxicodendron 1M HPUS, 10.8% Ruta Graveolens 1M HPUS, 10.8% Natrum Muraticum 2C HPUS, 10.8%

Purpose

Arnica Montana 1M HPUS, 10.8%................Bruising, Muscle Strain Hypericum Perforatum 1M HPUS, 10.8%.................Pain Ledum Palustre 1M HPUS, 10.8%..............Swelling, Pain Rhus Toxicodendron 1M HPUS, 10.8%................Sprains, Strains, Swelling, Pain Ruta Graveolens 1M HPUS, 10.8%..............Strains Natrum Muraticum 2C HPUS, 10.8%......................Sprains The letter HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Purpose

Arnica Montana 1M HPUS, 10.8%................Bruising, Muscle Strain

Hypericum Perforatum 1M HPUS, 10.8%.................Pain

Ledum Palustre 1M HPUS, 10.8%..............Swelling, Pain

Rhus Toxicodendron 1M HPUS, 10.8%................Sprains, Strains, Swelling, Pain

Ruta Graveolens 1M HPUS, 10.8%..............Strains

Natrum Muraticum 2C HPUS, 10.8%......................Sprains

The letter HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Description

Arnica Montana 1M HPUS, 10.8% Hypericum Perforatum 1M HPUS, 10.8% Ledum Palustre 1M HPUS, 10.8% Rhus Toxicodendron 1M HPUS, 10.8% Ruta Graveolens 1M HPUS, 10.8% Natrum Muraticum 2C HPUS, 10.8%

Uses

For the reduction of swelling and pain associated with joint sprains, muscle strains, dislocations, overuse injuries and bruising.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

​Stop use and ask a doctor if

  • condition worsens
  • irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
Section 50570-1

Do not use if you are allergic to any of this product's active or inactive ingredients.

Section 53414-9

I f pre gnant or breastfeeding, ask a health professional before use.

Warnings

For external use on intact skin only

Directions

Adults and children 12 years of age and over

  • Clean and dry affected area
  • Remove patch from film
  • Place healing patch on intact skin
  • Wear one ActivMend patch up to 24 hours.

Children under 12 years of age

Consult a doctor

Questions?

1-855-255-MEND or email: [email protected]

Other Information
  • Do not use if pouch is opened or damaged
  • Tightly reseal pouch containing unused patches
  • Store at room temperature
  • Do not freeze
Active Ingredients

Arnica Montana 1M HPUS, 10.8%

Hypericum Perforatum 1M HPUS, 10.8%

Ledum Palustre 1M HPUS, 10.8%

Rhus Toxicodendron 1M HPUS, 10.8%

Ruta Graveolens 1M HPUS, 10.8%

Natrum Muraticum 2C HPUS, 10.8%

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Edetate disodium, Ethanol, Glycerin, 1,2-hexanediol, Partially neutralized polyacrylate, Sodium carboxymethyl cellulose, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Principal Display Panel

NDC #76277-122-32

ActivMend

Healing gel patches for the reduction of pain, swelling and bruising.

5 Homeopathic Recovery Patches Per Box

4" x 5.5" Each

(10 cm x 14 cm)


Structured Label Content

Uses

For the reduction of swelling and pain associated with joint sprains, muscle strains, dislocations, overuse injuries and bruising.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

​Stop use and ask a doctor if

  • condition worsens
  • irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
Section 50570-1 (50570-1)

Do not use if you are allergic to any of this product's active or inactive ingredients.

Section 53414-9 (53414-9)

I f pre gnant or breastfeeding, ask a health professional before use.

Purpose

Arnica Montana 1M HPUS, 10.8%................Bruising, Muscle Strain

Hypericum Perforatum 1M HPUS, 10.8%.................Pain

Ledum Palustre 1M HPUS, 10.8%..............Swelling, Pain

Rhus Toxicodendron 1M HPUS, 10.8%................Sprains, Strains, Swelling, Pain

Ruta Graveolens 1M HPUS, 10.8%..............Strains

Natrum Muraticum 2C HPUS, 10.8%......................Sprains

The letter HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Warnings

For external use on intact skin only

Directions

Adults and children 12 years of age and over

  • Clean and dry affected area
  • Remove patch from film
  • Place healing patch on intact skin
  • Wear one ActivMend patch up to 24 hours.

Children under 12 years of age

Consult a doctor

Questions?

1-855-255-MEND or email: [email protected]

Other Information (Other information)
  • Do not use if pouch is opened or damaged
  • Tightly reseal pouch containing unused patches
  • Store at room temperature
  • Do not freeze
Active Ingredients (Active ingredients)

Arnica Montana 1M HPUS, 10.8%

Hypericum Perforatum 1M HPUS, 10.8%

Ledum Palustre 1M HPUS, 10.8%

Rhus Toxicodendron 1M HPUS, 10.8%

Ruta Graveolens 1M HPUS, 10.8%

Natrum Muraticum 2C HPUS, 10.8%

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum aminoacetate, Edetate disodium, Ethanol, Glycerin, 1,2-hexanediol, Partially neutralized polyacrylate, Sodium carboxymethyl cellulose, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Principal Display Panel

NDC #76277-122-32

ActivMend

Healing gel patches for the reduction of pain, swelling and bruising.

5 Homeopathic Recovery Patches Per Box

4" x 5.5" Each

(10 cm x 14 cm)


Advanced Ingredient Data


Raw Label Data

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