CARE AND COMFORT CREAM- aconitum napellus, arnica montana, bryonia (alba), calendula officinalis, chamomilla, colocynthis, hypericum perforatum, pulsatilla (pratensis), rhus tox, symphytum officinale cream 
Energique, Inc.

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 FACTS:

ACTIVE INGREDIENTS

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:

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:

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:

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

DIRECTIONS:

Apply at least 3 times daily over the affected area.

INDICATIONS:

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:

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:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CARE AND 

COMFORT CREAM

Net wt. 2 oz. (57 g)

Care and Comfort Cream

CARE AND COMFORT CREAM 
aconitum napellus, arnica montana, bryonia (alba), calendula officinalis, chamomilla, colocynthis, hypericum perforatum, pulsatilla (pratensis), rhus tox, symphytum officinale cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0639
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE12 [hp_X]  in 1 g
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE12 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE12 [hp_X]  in 1 g
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP12 [hp_X]  in 1 g
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE12 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_X]  in 1 g
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE12 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
WHEY (UNII: 8617Z5FMF6)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SORBIC ACID (UNII: X045WJ989B)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
JOJOBA OIL (UNII: 724GKU717M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0639-157 g in 1 TUBE; Type 0: Not a Combination Product05/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/12/2022
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0639) , api manufacture(44911-0639) , label(44911-0639) , pack(44911-0639)

Revised: 5/2022
Document Id: f89830b7-a125-4b13-a819-bc91baf29f9a
Set id: ac8ee81f-0af4-46d4-b63f-beeb7d120f80
Version: 1
Effective Time: 20220512
 
Energique, Inc.