Pain and Inflammation Relief Foam: Homeopathic Product Information

PAIN AND INFLAMMATION RELIEF FOAM- calendula officinalis flowering top, croton tiglium seed, sodium chloride, plantago major whole, toxicodendron pubescens leaf and smilax ornata root liquid
The Magni Company

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

INDICATIONS:

Temporary relief from minor aches and pains of sore muscles and joints due to inflammation associated with:

• Arthritis

• Strains

• Sprains

• Trauma

WARNINGS:

Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away • For external use only

• Avoid contact with eyes • If symptoms persist for more than 7 days or worsen, consult your physician

OTHER INFORMATION:

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

Tamper resistant: Do not use if seal is broken.

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.

DIRECTIONS:

Apply to affected areas up to 4 times a day

INDICATIONS:

Temporary relief from minor aches and pains of sore muscles and joints due to inflammation associated with:

• Arthritis

• Strains

• Sprains

• Trauma

INACTIVE INGREDIENTS:

Aloe Vera Leaf Juice, Caprylyl Glycol, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Dragon’s Blood Croton (Croton lechleri) Sap, Ethanol, Extract Blend (Arnica [Arnica montana] Flower, Ascorbic Acid, Chaparral [Larrea tridentata] Leaf, Comfrey [Symphytum officinale] Leaf, English Lavender [Lavandula angustifolia] Buds, Lemon Balm [Melissa officinalis] Leaf, Poke [Phytolacca americana] Root, Purified Water, St. John’s Wort [Hypericum perforatum] Aerial Parts, White Willow [Salix alba] Bark, Yarrow [Achillea millefolium] Flower), Glycerin, Ionic Colloidal Silver, Methyl Gluceth-10, PEG-8 Dimethicone, PEG-14, PEG-33, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Sodium Cocoyl Isethionate, Sorbic Acid, Tocopherols (soy), Whey Protein Concentrate (milk).

QUESTIONS:

Dist. by: The Magni Group, Inc.

McKinney, TX 75072 USA

www.magnilife.com

1-800-645-9199

PACKAGE LABEL DISPLAY:

NEW

HOMEOPATHIC

NDC: 43689-0044-1

MAGNI LIFE

PAIN &

INFLAMMATION

RELIEF FOAM

Rapid pain relief due

to inflammation

√ Muscle pain
√ Joint pain
√ Arthritis
√ Stiffness
√ Swelling


NET WT 4 FL OZ (118mL)

Pain & Inflammation Relief FoamPain & Inflammation Relief Foam
PAIN AND INFLAMMATION RELIEF FOAM
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0044
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 mL
CROTON TIGLIUM SEED (CROTON TIGLIUM SEED) CROTON TIGLIUM SEED 30 [hp_X] in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 mL
PLANTAGO MAJOR WHOLE (PLANTAGO MAJOR) PLANTAGO MAJOR WHOLE 30 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 mL
SMILAX ORNATA ROOT (SARSAPARILLA) SMILAX ORNATA ROOT 30 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
ARNICA MONTANA FLOWER
LARREA TRIDENTATA LEAF
DISODIUM LAURETH SULFOSUCCINATE
SODIUM COCOYL ISETHIONATE
COCAMIDOPROPYL BETAINE
COMFREY LEAF
CROTON LECHLERI RESIN
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER
METHYL GLUCETH-10
GLYCERIN
SILVER
MELISSA OFFICINALIS LEAF
POLYETHYLENE GLYCOL 1600
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 700
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
PHYTOLACCA AMERICANA ROOT
POTASSIUM SORBATE
WATER
SODIUM BICARBONATE
ST. JOHN’S WORT
TOCOPHEROL
ASCORBIC ACID
WHEY
SALIX ALBA BARK
ACHILLEA MILLEFOLIUM FLOWER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43689-0044-1 118 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/03/2020
Labeler — The Magni Company (113501902)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (43689-0044), api manufacture (43689-0044), label (43689-0044), pack (43689-0044)

Revised: 08/2020 The Magni Company

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