Label: RESTFUL LEGS- arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, soluble
- NDC Code(s): 54973-3162-1, 54973-3162-2
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 7, 2022
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- PURPOSE
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Drug Facts
Active ingredients
Active ingredients Purpose Arsenicum Album 12X HPUS
(0.000000000076% Arsenic, calculated)
creeping, crawling itch Lycopodium 6X HPUS feeling of agitation while lying down Pulsatilla 6X HPUS constant urge to move legs Rhus Toxicodendron 6X HPUS agitation, better with activity Sulphur 6X HPUS itching, tingling and urge to move legs Zincum Metallicum 12X HPUS twitching and jerking of legs while sitting "HPUS" is the Homeopathic Pharmacopoeia of the United States.
- Uses
- Directions
- Warnings
- Inactive Ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- **THIS PRODUCT IS NOT INTENDED TO TREAT RESTLESS LEG SYNDROME.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESTFUL LEGS
arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3162-1 1 in 1 CARTON 07/17/2006 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3162-2 4 in 1 PACKET; Type 0: Not a Combination Product 07/17/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/17/2006 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3162) , pack(54973-3162) , label(54973-3162) Establishment Name Address ID/FEI Business Operations MeriCal, Inc. 118445308 manufacture(54973-3162)