Label: THERAGOLD- arnica montana, melissa officinalis seed oil, calendula officinalis flower, capsicum cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71940-001-50 - Packager: Square One New Zealand Llc.
- 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 May 1, 2018
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- Active Ingredients
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- Inactive Ingredients
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- Principal Display Panel - TheraGold Jar Label
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INGREDIENTS AND APPEARANCE
THERAGOLD
arnica montana, melissa officinalis seed oil, calendula officinalis flower, capsicum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71940-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 3 [hp_X] in 50 g Melissa Officinalis Seed Oil (UNII: MJ76269K9S) (Melissa Officinalis Seed Oil - UNII:MJ76269K9S) Melissa Officinalis Seed Oil 3 [hp_X] in 50 g Calendula Officinalis Flower (UNII: P0M7O4Y7YD) (Calendula Officinalis Flower - UNII:P0M7O4Y7YD) Calendula Officinalis Flower 3 [hp_X] in 50 g Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 3 [hp_X] in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Peppermint Oil (UNII: AV092KU4JH) Ginger Oil (UNII: SAS9Z1SVUK) Honey (UNII: Y9H1V576FH) Clary Sage Oil (UNII: 87L0D4U3M0) Cetyl Alcohol (UNII: 936JST6JCN) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Dimethicone (UNII: 92RU3N3Y1O) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Glyceryl Monostearate (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71940-001-50 25 in 1 CARTON 05/01/2018 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2018 Labeler - Square One New Zealand Llc. (080819801) Registrant - MaxPax, LLC (017038858) Establishment Name Address ID/FEI Business Operations MaxPAx, LLC 017038858 MANUFACTURE(71940-001)