Dr Joe Lab Pms Menstrual Pain Relief Oil
FDA Label NDC 82331-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr Joe Lab, Inc. for the product Dr Joe Lab Pms Menstrual Pain Relief Oil (NDC 82331-111). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 1.4%
Methyl Salicylate 10%
Purpose
Topical Analgesic
Uses
Temporarily relieves minor pain associated with menstrual cramps.
Warnings
For external use only
When using this product
• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin
Stop use and ask a doctor if
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops.
Allergy Alert
Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.
If pregnant or breast-feeding, 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 over 12 years of age:
• apply to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily.
Other Information
Protect the product in this container from excessive heat and direct sun. Store at 20-25°C (66-77°F).
Inactive Ingredients
Vitamin E, Butylated Hydroxytoluene, Isopropyl Myristate, Eucalyptus Leaf Oil.
Questions Or Comments?
1-855-349-7735 or visit www.drjoelab.com to report serious adverse events associated with use of the product.
Packaging
Dr.joe-111 (8233111104 3)
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