Label: LEG CRAMPS- aconitum napellus, arnica montana, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top ointment
- NDC Code(s): 54973-3202-1, 54973-3202-2
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 February 15, 2024
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- Purpose
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Drug Facts
Active ingredients
Active ingredients Purpose Aconitum Napellus 3X HPUS pain in joints and legs Arnica Montana 3X HPUS stiffness, muscle soreness and pain Ledum Palustre 3X HPUS pain and cramps in legs Magnesium Phosphorica 10X HPUS muscle cramps Rhus Toxicodendron 6X HPUS pain and stiffness Viscum Album 3X HPUS pain in joints "HPUS" is the Homeopathic Pharmacopoeia of the United States.
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- Inactive ingredients
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- HOMEOPATHIC ACTIVE INGREDIENTS 10%
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
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INGREDIENTS AND APPEARANCE
LEG CRAMPS
aconitum napellus, arnica montana, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 3 [hp_X] in 1 g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] in 1 g VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) YELLOW WAX (UNII: 2ZA36H0S2V) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) GLYCERIN (UNII: PDC6A3C0OX) CORN OIL (UNII: 8470G57WFM) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3202-1 1 in 1 CARTON 05/12/2015 1 70.9 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:54973-3202-2 10 g in 1 TUBE; Type 0: Not a Combination Product 05/12/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/12/2015 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 pack(54973-3202) , manufacture(54973-3202) , label(54973-3202)