Wart (Baryta Carbonica, Antimonium Crudum, Causticum, Dulcamara, Nitricum Acidum, Silicea, Staphysagria, Thuja Occidentalis, Calcarea Carbonica, Sepia) Gel [Engergique, Inc.] -

WART (BARYTA CARBONICA, ANTIMONIUM CRUDUM, CAUSTICUM, DULCAMARA, NITRICUM ACIDUM, SILICEA, STAPHYSAGRIA, THUJA OCCIDENTALIS, CALCAREA CARBONICA, SEPIA) GEL [ENGERGIQUE, INC.]
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NDC	44911-0130-1
Set ID	6e06e3ea-5107-440e-9e4a-01434bbbf55a
Category	HUMAN OTC DRUG LABEL
Packager	Engergique, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

BARYTA CARBONICA 12X, ANTIMONIUM CRUDUM 30X, CAUSTICUM 30X, DULCAMARA 30X, NITRICUM ACIDUM 30X, SILICEA 30X, STAPHYSAGRIA 30X, THUJA OCCIDENTALIS 30X, CALCAREA CARBONICA 30C, SEPIA 30C
INDICATIONS:

For temporary relief of common and plantar warts.**

**These statements are based upon traditional homeopathic practice. They have not been evaluated 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 topically twice daily.
INDICATIONS:

For temporary relief of common and plantar warts.**

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

Alcohol (SDA 40), Carbomer (polymer), Glycerin, NaPCA (natural hydration factor), Sodium Hyaluronate, Sodium Hydroxymethylglycinate (preservative derived from amino acid glycine) Tromethamine (amine based organic buffer), Water, Xanthan Gum.
QUESTIONS:

Dist. by Energique., 201 Apple Blvd.

Woodbine, IA 51579 800.869.8078
PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

WART GEL

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

WART
baryta carbonica, antimonium crudum, causticum, dulcamara, nitricum acidum, silicea, staphysagria, thuja occidentalis, calcarea carbonica, sepia gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	12 [hp_X] in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	30 [hp_X] in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	30 [hp_X] in 1 g
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	30 [hp_X] in 1 g
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	30 [hp_X] in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X] in 1 g
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_X] in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X] in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C] in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
TROMETHAMINE (UNII: 023C2WHX2V)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44911-0130-1	57 g in 1 TUBE; Type 0: Not a Combination Product	12/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/03/2014

Labeler - Engergique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0130) , api manufacture(44911-0130) , label(44911-0130) , pack(44911-0130)

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Medic

WART (BARYTA CARBONICA, ANTIMONIUM CRUDUM, CAUSTICUM, DULCAMARA, NITRICUM ACIDUM, SILICEA, STAPHYSAGRIA, THUJA OCCIDENTALIS, CALCAREA CARBONICA, SEPIA) GEL [ENGERGIQUE, INC.]

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