Phytogel

Phytogel
SPL v9
SPL
SPL Set ID e94b4f4c-bf4e-4210-a4e1-f2b7341e6dcc
Route
TOPICAL
Published
Effective Date 2022-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X]) Calendula Officinalis Flowering Top (12 [hp_X]) Hypericum Perforatum (30 [hp_X]) Bellis Perennis (30 [hp_C]) Fluoride Ion (6 [hp_X]) Ferrosoferric Phosphate Ledum Palustre Twig Sodium Sulfate Anhydrous Toxicodendron Pubescens Leaf Sulfuric Acid Comfrey Root
Inactive Ingredients
Aloe Vera Leaf Water Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Phenoxyethanol Ethylhexylglycerin Potassium Sorbate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-06-15

Description

Active ingredients 2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of Arnica 1X, Calendula 1X, Hypericum 1X. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

Warnings

  • If swallowed, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast feeding,ask a health professional before use.
  • For external use only. Do not apply to open wounds.
Indications and Usage

Uses Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin

irritations, and muscle aches.

Dosage and Administration

Directions

  • Apply topically three times daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
Description

Active ingredients 2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of Arnica 1X, Calendula 1X, Hypericum 1X. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive  ingredients Aloe Barbadensis (Aloe Vera) Leaf Juice, Purified Water, Ethanol, Carbomer, remaining ingredients at ≤ 1%: Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide.

Section 51945-4

PhytoGel

Topical, homeopathic pain-relief gel

Pain related to sprains, strains,

bruises, joints, burns,

sunburns, insect bites, skin

irritations, and muscle aches

2 oz (56.7 g)

Section 53413-1

Distributed by Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.energetix.com

Section 55105-1



Purpose Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscle aches

Section 55106-9

Active ingredients

2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus

tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of

Arnica 1X, Calendula 1X, Hypericum 1X.

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

Section 60561-8

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if tamper evident seal is broken or missing.

Structured Label Content

Indications and Usage (34067-9)

Uses Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin

irritations, and muscle aches.

Dosage and Administration (34068-7)

Directions

  • Apply topically three times daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
Warnings and Precautions (34071-1)

Warnings

  • If swallowed, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast feeding,ask a health professional before use.
  • For external use only. Do not apply to open wounds.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive  ingredients Aloe Barbadensis (Aloe Vera) Leaf Juice, Purified Water, Ethanol, Carbomer, remaining ingredients at ≤ 1%: Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide.

Section 51945-4 (51945-4)

PhytoGel

Topical, homeopathic pain-relief gel

Pain related to sprains, strains,

bruises, joints, burns,

sunburns, insect bites, skin

irritations, and muscle aches

2 oz (56.7 g)

Section 53413-1 (53413-1)

Distributed by Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.energetix.com

Section 55105-1 (55105-1)



Purpose Temporary relief of pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscle aches

Section 55106-9 (55106-9)

Active ingredients

2 oz contains 1.638% of Arnica 30C, Bellis 12X, Calc fluor 30X, Ferrum phos 30X, Hypericum 30C, Ledum 12X, Nat sulphuricum 30C, Rhus

tox 30X, Sulphuricum ac 12X, Symphytum 6X; 0.54% of

Arnica 1X, Calendula 1X, Hypericum 1X.

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

Section 60561-8 (60561-8)

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if tamper evident seal is broken or missing.

Advanced Ingredient Data


Raw Label Data

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