The following Structured Product Label (SPL) was submitted to the FDA by Biolyte Laboratories, Llc for the product Neorelief For Menstrual Pain And Cramps (NDC 58368-003). 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, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
All actives are HPUS* and 4X potency.
Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina
Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum
Tilia
*HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.
Topical Analgesics
Relief of Cramping
Anti-inflammatory
For temporary relief of menstrual symptoms such as:
Menstrual pain, Cramping
Indications are based on homeopathic materia medica, not clinical tests.
For external use only
Do not use on damged or broken skin.
Keep out of eyes, open wounds, mucous membranes
Stop use and ask doctor if:
Condition worsens or persists,
rash develops
If pregnant or breastfeeding consult your doctor before use.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Women ages 8 years and older, spread thin layer on lower abdomen and lower back.
Do not apply over other topical lotions; they may hinder effectiveness.
Apply as needed for relief.
Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact.
Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.
800.538.1455
Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at neorelief.com.
Reporty any serious side effects to the number above.
Packaging Recyclable
Made in the USA
Listed with the FDA
neorelief.com
Drug Facts continued peel here
FTC required disclosure: Product efficacy and claims are based on theories of homeopathy that re not supported by scientific evidence and most modern allopathic medical professionals.
BioLyte Labs Grand Rapids, MI 49534
NDC 58368-003-03 Patent Pending
Neo Relief
Temporary relief of
Menstrual pain & cramps
Homeopathic pain relief gel
Net Wt. 0.5 oz (14.17g)
Neorelief_menstural (Neorelief Formenstrualpaincramps.5oz)
* Please review the disclaimer below.
