Label: COLD HANDS - FEET- histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum alb., bryonia, cactus, calc. fluor., ceanothus, cinchona, convallaria, digitalis, gelsemium, glonoinum, hydrocoyle, kali carb., lachesis, naja, nat carb., nat mur., nux vom., phosphorus, pullsatilla, rhus toxicodendron, strophanthus hispidus, sulphur, echinacea liquid
- NDC Code(s): 55714-2404-0, 55714-2404-1
- Packager: Newton Laboratories, 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 November 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- WARNINGS SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- DOSAGE & ADMINISTRATION SECTION
-
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Aconitum nap. 15x, Arsenicum alb. 15x, Bryonia 15x, Cactus 15, Calc. fluor. 15x, Ceanothus 15x, Cinchona 15x, Convallaria 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Histaminum hydrochloricum 15x, Hydrocotyle 15x, Kali carb. 15x, Lachesis 15x, Naja 15x, Nat. carb. 15x, Nat. mur. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Strophanthus hisp. 15x, Sulphur 15x, Thyroidinum 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- INDICATIONS & USAGE SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
COLD HANDS - FEET
histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum alb., bryonia, cactus, calc. fluor., ceanothus, cinchona, convallaria, digitalis, gelsemium, glonoinum, hydrocoyle, kali carb., lachesis, naja, nat carb., nat mur., nux vom., phosphorus, pullsatilla, rhus toxicodendron, strophanthus hispidus, sulphur, echinacea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2404 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 15 [hp_X] in 1 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 15 [hp_X] in 1 mL ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM 15 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 15 [hp_X] in 1 mL CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N) CEANOTHUS AMERICANUS LEAF 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS 15 [hp_X] in 1 mL DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 15 [hp_X] in 1 mL CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 15 [hp_X] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 15 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 15 [hp_X] in 1 mL NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM 15 [hp_X] in 1 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 15 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED 15 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2404-0 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/08/2018 08/01/2019 2 NDC:55714-2404-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/08/2018 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2404)
