Label: CARE AND COMFORT CREAM (aconitum napellus, arnica montana, bryonia (alba), calendula officinalis, chamomilla, colocynthis, hypericum perforatum, pulsatilla- pratensis, rhus tox, symphytum officinale cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 44911-0639-1 - Packager: Energique, 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 May 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INDICATIONS:
-
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:
- DIRECTIONS:
- INDICATIONS:
-
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:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
CARE AND COMFORT CREAM
aconitum napellus, arnica montana, bryonia (alba), calendula officinalis, chamomilla, colocynthis, hypericum perforatum, pulsatilla (pratensis), rhus tox, symphytum officinale creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0639 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 12 [hp_X] in 1 g ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 12 [hp_X] in 1 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 12 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 g MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 12 [hp_X] in 1 g CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 12 [hp_X] in 1 g HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 12 [hp_X] in 1 g PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 12 [hp_X] in 1 g PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 12 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 12 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0639-1 57 g in 1 TUBE; Type 0: Not a Combination Product 05/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/12/2022 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0639) , api manufacture(44911-0639) , label(44911-0639) , pack(44911-0639)
