Frankincense And Myrrh Arthritis Pain Therapy Lotion
FDA Label NDC 42346-730

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wise Consumer Products Co. for the product Frankincense And Myrrh Arthritis Pain Therapy (NDC 42346-730). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

Active Ingredients

Hypericum perforatum 3X HPUS*

Purpose

Hypericum perforatum 3X HPUS*........Topical Analgesic

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

For the temporary relief of minor aches and pains.

Warnings

For external use only

Otc - Do Not Use

Do not use

on wounds or damaged skin
over large areas of the body

Otc - When Using

When using this product

avoid contact with the eyes
do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Other Information

store in a cool, dry place.
tamper resistant: do not use if seal under tube cap is broken or missing.
claims based on traditional homeopathc practice; not accepted mediacl evidence. Not FDA evaluated.

Inactive Ingredients

Water, Caprylic/Capric Triglycerides, Emulsifying wax, Cocos Nucifera (Coconut) Oil, Butyrospermum parkii (shea) butter, Lanolin, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens (Geranium) Flower Oil, Sodium Hydroxide, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Xanthan gum, Methyl paraben, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Propylparaben, Menthol, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Limon (Lemon) Peel Oil