TRAUMA PLUS GEL- calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, ledum palustre, sulphuricum acidum, calcarea fluorica, ferrum phosphoricum, rhus tox, ruta graveolens, natrum sulphuricum gel 
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 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

INDICATIONS:

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

**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 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 small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

INDICATIONS:

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

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

INACTIVE INGREDIENTS:

Purified Water, Whey Protein Concentrate (milk), Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Sodium Hydroxide (Solution), Edetate Disodium (EDTA).

QUESTIONS:

Dist. by Energique, Inc., 201 Apple Blvd.
Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMA+GEL

Net wt. 2 oz. (57 g)

Trauma+Gel (Pain)

TRAUMA PLUS GEL 
calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, ledum palustre, sulphuricum acidum, calcarea fluorica, ferrum phosphoricum, rhus tox, ruta graveolens, natrum sulphuricum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0446
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 TOP1 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG12 [hp_X]  in 1 g
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 1 g
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_X]  in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
WHEY (UNII: 8617Z5FMF6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0446-157 g in 1 TUBE; Type 0: Not a Combination Product02/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/08/2018
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0446) , api manufacture(44911-0446) , label(44911-0446) , pack(44911-0446)

Revised: 2/2018
Document Id: a953cf42-4285-40cb-a1fe-f84a6b365987
Set id: 6da04ff9-4088-427c-9757-36092c8f7585
Version: 1
Effective Time: 20180208
 
Energique, Inc.