Cold Hands - Feet
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-11-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:13:36
Label at a glance#
ProductCold Hands - Feet
Active ingredientHISTAMINE DIHYDROCHLORIDE, THYROID, UNSPECIFIED, ACONITUM NAPELLUS, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, SELENICEREUS GRANDIFLORUS STEM, CALCIUM FLUORIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, CONVALLARIA MAJALIS, DIGITALIS, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, CENTELLA ASIATICA, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, NAJA NAJA VENOM, SODIUM CARBONATE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, STROPHANTHUS HISPIDUS SEED, SULFUR, ECHINACEA, UNSPECIFIED
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
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
Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.
INACTIVE INGREDIENT SECTION
USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
QUESTIONS SECTION
newtonlabs.net - Questions? 800 448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2404-0 | Cold Hands - Feet | 15 mL in 1 BOTTLE, GLASS | LIQUID | 15 | 3 | |
| 55714-2404-1 | Cold Hands - Feet | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2404 | 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 [NEWTON LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20201125_7a2b4f28-2128-a8b2-e053-2a91aa0a2402.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- ALCOHOL
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- THYROID, UNSPECIFIED
- ACONITUM NAPELLUS
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BRYONIA ALBA ROOT
- SELENICEREUS GRANDIFLORUS STEM
- CALCIUM FLUORIDE
- FLUORIDE ION
- CEANOTHUS AMERICANUS LEAF
- CINCHONA OFFICINALIS BARK
- CONVALLARIA MAJALIS
- DIGITALIS
- GELSEMIUM SEMPERVIRENS ROOT
- NITROGLYCERIN
- CENTELLA ASIATICA
- POTASSIUM CARBONATE
- CARBONATE ION
- LACHESIS MUTA VENOM
- NAJA NAJA VENOM
- SODIUM CARBONATE
- SODIUM CHLORIDE
- CHLORIDE ION
- STRYCHNOS NUX-VOMICA SEED
- PHOSPHORUS
- PULSATILLA VULGARIS
- TOXICODENDRON PUBESCENS LEAF
- STROPHANTHUS HISPIDUS SEED
- SULFUR
- ECHINACEA, UNSPECIFIED
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2404 | 55714-2404-0, 55714-2404-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 | 2020-11-24 | Warnings | 55714-2404-0 55714-2404-1 55714-2404 55714240401 55714240400 b4e0ae97-f187-58c9-e053-2a95a90a0da2 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.