Label: FOOT PAIN RELIEVING- apis mellifica, gelsemium sempervirens, gnaphalium spray
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Contains inactivated NDC Code(s)
NDC Code(s): 43689-0040-1 - Packager: The Magni Group 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 December 29, 2020
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- Active Ingredients (In Spray) - Purpose Apis Mellifica 3X HPUS - Relieves Foot Pain Gnaphalium 3X HPUS - Relieves Foot Pain Gelsemium Sempervirens 6X HPUS - External Analgesic
- Purpose: Relieves Foot Pain External Analgesic
- Use: Temporarily relieves foot pain
- Keep out of reach of children
- Warning: For external use only
- When using this product: - Avoid contact with eyes
- If symptoms persist for more than 7 days or worsen, consult your physician
- Do not use on open wounds, cuts, damaged, or infected skin
- Directions: - Adults and children 12 years of age and older, apply to all surfaces of the feet, heels and toes up to four times daily - Apply to legs as needed
- Other information: - Most beneficial when applied after bathing, showering, or a foot soak - The letter "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States - These statements are supported by the traditional homeopathic principles
- Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzoic Acid, Bergamot Oil, C14-22 Alcohol/C12-20 Alkyl Glucoside, Canola Oil, Camphor Gum, Citric Acid, Ethylhexyl Stearate, Eucalyptus Oil, Glycerin, Mentha Piperita (Peppermint) Extract, Menthol, Methyl Salicylate, Panthenol, Phenoxyethanol, Sodium Hydroxide, Sorbic Acid, Tocopheryl Acetate, Water (Aqua), Xanthan Gum
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INGREDIENTS AND APPEARANCE
FOOT PAIN RELIEVING
apis mellifica, gelsemium sempervirens, gnaphalium sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43689-0040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 3 [hp_X] in 100 g GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 100 g PSEUDOGNAPHALIUM LUTEOALBUM LEAF (UNII: BGI20Z6M57) (PSEUDOGNAPHALIUM LUTEOALBUM LEAF - UNII:BGI20Z6M57) PSEUDOGNAPHALIUM LUTEOALBUM LEAF 3 [hp_X] in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SORBIC ACID (UNII: X045WJ989B) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) C14-22 ALCOHOLS (UNII: B1K89384RJ) CANOLA OIL (UNII: 331KBJ17RK) METHYL SALICYLATE (UNII: LAV5U5022Y) MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) BERGAMOT OIL (UNII: 39W1PKE3JI) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) BENZOIC ACID (UNII: 8SKN0B0MIM) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) SODIUM HYDROXIDE (UNII: 55X04QC32I) PANTHENOL (UNII: WV9CM0O67Z) EUCALYPTUS OIL (UNII: 2R04ONI662) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43689-0040-1 85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/29/2020 Labeler - The Magni Group Inc (113501902) Establishment Name Address ID/FEI Business Operations United Laboratories Manufacturing LLC 807878116 manufacture(43689-0040)