FDA.reportPublic FDA data

Care and Comfort Cream

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:28

Label at a glance#

ProductCare and Comfort Cream
Active ingredientACONITUM NAPELLUS WHOLE, ARNICA MONTANA WHOLE, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP, HYPERICUM PERFORATUM WHOLE, PHYTOLACCA AMERICANA ROOT, PULSATILLA PRATENSIS WHOLE, TOXICODENDRON PUBESCENS LEAF, COMFREY ROOT
Label structure9 sections

Dosage and administration

Apply at least 3 times daily over the affected area.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

0.09% of Aconitum Napellus 12X, Arnica Montana 12X, Bryonia (Alba) 12X, Calendula Officinalis 12X, Chamomilla 12X, Colocynthis 12X, Hypericum Perforatum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Symphytum Officinale 12X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain, soreness, swelling, stiffness, and symptoms of minor injuries.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Do not expose product to extreme temperatures.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over the affected area.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain, soreness, swelling, stiffness, and symptoms of minor injuries.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Whey protein concentrate (milk), Benzyl alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Vera leaf juice, Jojoba (Simmondsia Chinensis) Seed Oil, English Lavender (Lavandula Angustifolia) flower oil, Methyl Gluceth-10, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lauryl Glucoside, Myristyl Glucoside, Polyglyceryl-6 Laurate, Sodium Gluconate, Tocopherols (soy), Salicylic Acid, Sorbic Acid, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CARE AND 

COMFORT CREAM

Net wt. 2 oz. (57 g)

Care and Comfort CreamCare and Comfort Cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0639-12024-10-24C16284748780-11030e365-112a-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0639-12024-01-30C16284748780-11030e365-112a-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0639-1Care and Comfort Cream57 g in 1 TUBECREAM572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0639CARE AND COMFORT CREAM (ACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALE) CREAM [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20241027_ac8ee81f-0af4-46d4-b63f-beeb7d120f80.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-063944911-0639-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
COMFREY ROOTM9VVZ08EKQACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
WHEY8617Z5FMF6IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
BENZYL ALCOHOLLKG8494WBHIACT
SALICYLIC ACIDO414PZ4LPZIACT
SORBIC ACIDX045WJ989BIACT
METHYL GLUCETH-10N0MWT4C7WHIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
MYRISTYL GLUCOSIDE6AK28695LFIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL724GKU717MIACT
LAVENDER OILZBP1YXW0H8IACT
SODIUM GLUCONATER6Q3791S76IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Care and Comfort CreamACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALEEnergique, Inc.ac8ee81f-0af4-46d4-b63f-beeb7d120f802024-10-24WarningsExact identifier
ndc (package): 44911-0639-1
ndc (product): 44911-0639
ndc11 (package): 44911063901
spl id: e596a666-541c-4807-a70c-4befd9813b42
spl set id: ac8ee81f-0af4-46d4-b63f-beeb7d120f80

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.