SPL v2
SPL
SPL Set ID b4511e83-e339-7105-e053-2995a90afd23
Route
TOPICAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X]) Black Cohosh Stellaria Media Atropa Belladonna Bryonia Alba Root Frangula Californica Bark Rhododendron Aureum Leaf Rhododendron Tomentosum Leafy Twig Hypericum Perforatum Caulophyllum Thalictroides Root
Inactive Ingredients
Anhydrous Citric Acid Water Medium-chain Triglycerides Methyl Glucose Dioleate Sodium Hydroxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cannabidiol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 114 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-01-21

Description

All active ingredients are HPUS* & 3X potency. Topical Analgesics - Belladonna, Bryonia Alba, Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Rhododendron Chrystanthum, Stellaria Media Arnica Montana........Anti-inflammatory *HPUS indicates the active ingredients are in the official Homoeopathic Pharmacopeia of the United States.


Medication Information

Description

All active ingredients are HPUS* & 3X potency. Topical Analgesics - Belladonna, Bryonia Alba, Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Rhododendron Chrystanthum, Stellaria Media Arnica Montana........Anti-inflammatory *HPUS indicates the active ingredients are in the official Homoeopathic Pharmacopeia of the United States.

Uses

For temporary relief of occasional:

• minor aches and pains of muscles and joints associated with

• simple backache • arthritis • strains • bruises • sprains

Indications are based on homeopathic materia medica not clinical tests.

Indications are based on theories of homeopathy that are not supported by scientific evidence and most modern allopathic medical professionals.

Section 51945-4

Warnings

For external use only.

Directions:

• Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.

• For best results, allow gel to be absorbed into the skin; do not rub in.

• Apply at the onset of symptoms, or every 15 minutes for the first hour, but not more than 6 times daily.

• Children under 2 years of age: Consult a doctor

Other Information

• Store in a cool, dry place.

• Avoid direct sunlight.

• Tamper-evident for your protection. Use only if safety seal is intact.

Active Ingredients

All active ingredients are HPUS* & 3X potency.

Topical Analgesics - Belladonna, Bryonia Alba, Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Rhododendron Chrystanthum, Stellaria Media

Arnica Montana........Anti-inflammatory

*HPUS indicates the active ingredients are in the official Homoeopathic Pharmacopeia of the United States.

Inactive Ingredients

Ethyl Alchohol, Purified Water, Medium Chain Triglyceride (MCT) Oil, Full Spectrum CBD Distillate, Sodium Hydroxide, Glucate DO, Carbomer, Citric Acid

Questions Or Comments?

(616) 884-0179 or visit us at BridgeStreetHemp.com

When Using This Product:

Avoid contact with eyes or mucous membranes • Do not use with other ointments, creams, or sprays • Do not apply over large areas of the body or bandage • Do not use with heating pad or device

Ask A Doctor Before Use If:

Taking a prescription drug or have a serious medical treatment.

Stop Use and Ask A Doctor If:

Conditions worsen, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

If Pregnant Or Breast Feeding:

ask a healthcare professional before use.

Keep Out of Reach of Children:

if accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

For temporary relief of occasional:

• minor aches and pains of muscles and joints associated with

• simple backache • arthritis • strains • bruises • sprains

Indications are based on homeopathic materia medica not clinical tests.

Indications are based on theories of homeopathy that are not supported by scientific evidence and most modern allopathic medical professionals.

Section 51945-4 (51945-4)

Warnings

For external use only.

Directions:

• Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.

• For best results, allow gel to be absorbed into the skin; do not rub in.

• Apply at the onset of symptoms, or every 15 minutes for the first hour, but not more than 6 times daily.

• Children under 2 years of age: Consult a doctor

Other Information

• Store in a cool, dry place.

• Avoid direct sunlight.

• Tamper-evident for your protection. Use only if safety seal is intact.

Active Ingredients

All active ingredients are HPUS* & 3X potency.

Topical Analgesics - Belladonna, Bryonia Alba, Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Rhododendron Chrystanthum, Stellaria Media

Arnica Montana........Anti-inflammatory

*HPUS indicates the active ingredients are in the official Homoeopathic Pharmacopeia of the United States.

Inactive Ingredients

Ethyl Alchohol, Purified Water, Medium Chain Triglyceride (MCT) Oil, Full Spectrum CBD Distillate, Sodium Hydroxide, Glucate DO, Carbomer, Citric Acid

Questions Or Comments? (Questions or Comments?)

(616) 884-0179 or visit us at BridgeStreetHemp.com

When Using This Product: (When using this product:)

Avoid contact with eyes or mucous membranes • Do not use with other ointments, creams, or sprays • Do not apply over large areas of the body or bandage • Do not use with heating pad or device

Ask A Doctor Before Use If: (Ask a doctor before use if:)

Taking a prescription drug or have a serious medical treatment.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Conditions worsen, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

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

ask a healthcare professional before use.

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

if accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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