Active Ingredient
Menthol 1.3%
Menthol 2%
Frankincense And Myrrh Nerve Combo Pack Kit
FDA Label NDC 42346-378
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 for the product Frankincense And Myrrh Nerve Combo Pack (NDC 42346-378). 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 - when using, otc - do not use, 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 1.3%......................Topical Analgesic
Menthol 2%......................Topical Analgesic
Uses
For the temporary relief of minor aches and pains.
For temporary relief of minor aches and pains
Warnings
For external use only
For external use only
Otc - When Using
When using this product
- avoid contact with the eyes
- do not bandage tightly
- avoid contact with the eyes
- do not bandage tightly
When using this product
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- over large areas of the body
- on wounds or damaged skin
- over large areas of the body
Do not use
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
- 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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.
Keep out of reacho f 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.
- 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
Other Information
- store in a cool, dry place
- tamper resistant: do not use if seal undertube cap is broken or missing
- 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
Inactive Ingredients
Bergamot Oil, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, Cinnamon Oil, Cocoa Butter, Coconut Oil, Eucalyptus Oil, Frankincense Oil, Geranium Oil, Glycerin, Glyceryl Stearate, Lanolin, Lemon Oil, Methylparaben, Myrrh Oil, Nutmeg Oil, Palmitic Acid, Polysorbate 60, Propylparaben, Rosemary Oil, Shea Butter, Sodium Hydroxide, Stearic Acid, Water, Xanthan Gum
Bergamot Oil, Cinnamon Oil, Eucalyptus Oil, Frankincense Oil, Geranium Oil, Lemon Oil, Myrrh Oil, Nutmeg Oil, Rosemary Oil, Sunflower Oil, Tocopheryl Acetate
Questions Or Comments?
1-877-917-9674 Monday – Friday, 9 a.m.–5 p.m. ESTor visit www.frankincensemyrrh.com
1-877-917-9674
M-F, 9am-5pm EST or www.frankincensemyrrh.com
Package Label.Principal Display Panel
Frankincense & Myrrh
Combo Pack
Deep Penetrating Relief
Menthol 2%
2 fl oz (59mL)
Menthol 1.3%
3 fl oz (85g)
* Please review the disclaimer below.
