Itchy Gone (Apis Mellifica, Belladonna, Calcarea Carbonica, Medusa, Mezereum, Rhus Toxicodendron, Astacus Fluviatilis, Chloralum,) Gel [Apotheca Company] -

ITCHY GONE (APIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEDUSA, MEZEREUM, RHUS TOXICODENDRON, ASTACUS FLUVIATILIS, CHLORALUM,) GEL [APOTHECA COMPANY]
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NDC	57520-0777-1
Set ID	f8b0646e-7d2a-4bed-9ed7-25253ec500d8
Category	HUMAN OTC DRUG LABEL
Packager	Apotheca Company
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Apis mellifica 12X, Belladonna 12X, Calcarea carbonica 12X, Medusa 12X, Mezereum 12X, Rhus toxicodendron 12X, Astacus fluviatilis 15X, Chloralum 15X.
PURPOSE

INDICATIONS: For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.
WARNINGS

WARNINGS: 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.

For topical use only.
DOSAGE & ADMINISTRATION

DIRECTIONS: Apply topically to affected area 4 to 6 times daily.
INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Aloe, Biosaccharide gum-1, Carbomer, Ethanol, Glycerin, NaPCA, Purified water, Sodium hydroxymethylglycinate, Tromethamine.
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away.
INDICATIONS & USAGE

INDICATIONS: For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.
QUESTIONS

Dist. By:

MedCare Group

Boothwyn, PA 19060

302-260-3111

www.medcaregroups.com
PRINCIPAL DISPLAY PANEL

MEDCARE

Itchy Gone

HOMEOPATHIC

Net Wt. 2 OZ

INGREDIENTS AND APPEARANCE

ITCHY GONE
apis mellifica, belladonna, calcarea carbonica, medusa, mezereum, rhus toxicodendron, astacus fluviatilis, chloralum, gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	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
ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ)	ASTACUS ASTACUS	15 [hp_X] in 1 g
CHLORAL HYDRATE (UNII: 418M5916WG) (CHLORAL - UNII:FLI06WS32H)	CHLORAL HYDRATE	15 [hp_X] in 1 g
PHYSALIA PHYSALIS (UNII: KT9FN2JQGF) (PHYSALIA PHYSALIS - UNII:KT9FN2JQGF)	PHYSALIA PHYSALIS	12 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
TROMETHAMINE (UNII: 023C2WHX2V)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0777-1	59.69 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/28/2011

Labeler - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture

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Medic

ITCHY GONE (APIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEDUSA, MEZEREUM, RHUS TOXICODENDRON, ASTACUS FLUVIATILIS, CHLORALUM,) GEL [APOTHECA COMPANY]

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