FIRST AID PAIN AND TRAUMA RELIEF- calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray 
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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

CALENDULA OFFICINALIS 12X, CROTON TIGLIUM 30X, NATRUM MURIATICUM 30X, PLANTAGO MAJOR 30X, RHUS TOX 30X, SARSAPARILLA (SIMILAX REGELII) 30X

INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: cuts and scrapes, burns including sunburn, abrasions, bruising**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

For external use only.

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 get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

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:

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: cuts and scrapes, burns including sunburn, abrasions, brusing**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENTS:

ALOE BARBADENSIS LEAF JUICE (ALOE VERA 10X CONCENTRATE), ARNICA MONTANA (FLOWER)*, LARREA TRIDENTATA (LEAF)*, SYMPHYTUM OFFICINALE (LEAF)*, CROTON LECHLERI (SAP), INSTANTIZED SOLUBLE EGGSHELL MEMBRANE + (BIOVADERM BRAND WITH 1% SUNFLOWER LECITHIN), LAVANDULA ANGUSTIFOLIA (BUDS)*, IONIC COLLOIDAL SILVER, MELISSA OFFICINALIS (LEAF)*, PEG-33, PEG-8 DIMETHICONE, PEG-14 (SILSENSE COPOLYOL-1 SILICONE), PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID (OPTIPHEN-PLUS), PHYTOLACCA AMERICANA (BERRIES)*, PHYTOLACCA AMERICANA (ROOT)*, POTASSIUM SORBATE, PURIFIED WATER, SODIUM BICARBONATE, HYPERICUM PERFORATUM (AERIAL PARTS)*, TOCOPHEROL [VITAMIN E OIL](DERIVED FROM SOY BEAN), VITAMIN C POWDER (ASCORBIC ACID), WHEY PROTEIN CONCENTRATE, SALIX ALBA (BARK)*, ACHILLEA MILLEFOLIUM (FLOWER)*

*EXTRACT

QUESTIONS:

Dist. by Energique, Inc.,  201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

FIRST AID PAIN & TRAUMA RELIEF

Topical Spray

1 fl. oz. (30 ml)

First Aid Pain & Trauma Relief

FIRST AID PAIN AND TRAUMA RELIEF 
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]  in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG) SMILAX ORNATA ROOT30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)  
COMFREY LEAF (UNII: DG4F8T839X)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
SILVER (UNII: 3M4G523W1G)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
WHEY (UNII: 8617Z5FMF6)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0135-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/30/201206/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/30/201206/22/2022
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0135) , api manufacture(44911-0135) , label(44911-0135) , pack(44911-0135)

Revised: 12/2021
 
Energique, Inc.