Active Ingredient
Menthol 2%
Menthol 1.3%
Frankincense And Myrrh Foot Pain Relief Oil
FDA Label NDC 42346-302
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 Foot Pain Relief (NDC 42346-302). 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 ingredient, 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
Purpose
Menthol 2% . . . . . . . . . . . . . . . . . Topical Analgesic
Menthol 1.3%................Topical Analgesic
Uses
For temporary relief of minor aches and pains.
For the temporary relief of minor aches and pains.
Warnings
For external use only
For external use only
Otc - Do Not Use
Do not use
on wounds or damaged skin
over large areas of the body
Do not use
on wounds or damaged skin
over large areas of the body
Otc - When Using
When using this product
avoid contact with eyes
do not bandage tightly
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
irritation occurs
symptoms persist for more than 7 days or clear up and occur again within a few days
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health care professional before use.
If pregnant or breastfeeding, ask a health professional before use.
Otc - 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.
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 10-30 drops into hand and massage into affected areas
can be used up to 4 times daily
children under 12 years of age: consult a doctor
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 around bottle neck is broken or missing
keep carton, it contains important information
- store in a cool, dry place
- tamper resistant: do not use if seal under tube cap is broken or missing
Inactive Ingredients
Helianthus Annuus (Sunflower) Seed Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens (Geranium) Leaf Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil,Tocopheryl Acetate.
Water, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Lanolin, Cetearyl Alcohol, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearyl, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 60, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol, Xanthan Gum, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Medica Limonum (Lemon) Peel Oil
Questions Or Comments?
1-877-917-9674
M-F, 9am-5pm EST or www.frankincensemyrrh.com
1-877-917-9674 Mon-Fri, 9 a.m. - 5 p.m. EST
www.frankincensemyrrh.com
Package Label.Principal Display Panel
Frankincense & Muyrrh Combo Pack
Safe for Diabetics
Foot Pain Relief
Fast Acting
Menthol 2%
2 fl oz (59 mL)
Menthol 1.3%
3 fl oz (85g)
* Please review the disclaimer below.
