Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU), PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)
The Magni Group Inc
TOPICAL
OTC DRUG
For temporary relief of leg discomfort with accompanying sleeplessness.
unapproved homeopathic
RELAXING LEG CREAM HOMEOPATHIC PM- CAUSTICUM, PSEUDOGNAPHALIUM OBTUSIFOLIUM CREAM THE MAGNI GROUP INC _Disclaimer: This homeopathic product has not been evaluated by the Food and Drug_ _Administration for safety or efficacy. FDA is not aware of scientific evidence to support_ _homeopathy as effective._ ---------- RELAXING LEG CREAM HOMEOPATHIC PM _DRUG FACTS_ _ACTIVE INGREDIENTS_ Causticum 8X HPUS Gnaphalium polycephalum 6X HPUS The letters 'HPUS' indiciate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States _PURPOSE_ Nighttime Sleep Aid Pain Reliever _USE_ For temporary relief of leg discomfort with accompanying sleeplessness. _WARNINGS_ FOR EXTERNAL USE ONLY. Avoid contact with eyes. _STOP AND ASK A DOCTOR_ if symptoms persist for more than 7 days or worsen. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Generously apply and massage into legs before bedtime. Reapply if necessary. _OTHER INFORMATION_ There is no scientific evidence that this product works. The product's claims are based on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. _INACTIVE INGREDIENTS_ Aloe Vera Leaf Juice, Benzocaine Hydrochloride, C13-14 Isoparaffin, Diazolidinylurea, English Lavender Oil, Folic Acid, Laureth-7, Magnesium Ascorbyl Phosphate, Methylparaben, Polyacrylamide, Propylene Glycol, Propylparaben, Retinyl Palmitate, Roman Chamomile Flower Extract, Sage Leaf Extract, Soybean Oil, Tocopheryl Acetate, Water, Ylang Ylang Flower Extract _PACKAGE LABELING:_ RELAXING LEG CREAM HOMEOPATHIC PM causticum, pseudognaphalium obtusifolium cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:43689-0027 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 8 [hp_X] in 113 g PSEUDOGNAP Read the complete document