BLACK- echinacea ang., hydrastis, phytolacca, plantago, stellaria med., symphytum, trifolium prat., verbascum, arsenicum alb., bufo, lachesis, lycopodium, sepia, silicea, thuja occ. gel

BLACK by

Drug Labeling and Warnings

BLACK by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: (HPUS*): Echinacea Ang 1X, Hydrastis 1X, Phytolacca 1X, Plantago 1X, Stellaria Med 1X, Symphytum 1X, Trifolium Prat 1X, Verbascum 1X, Arsenicum Alb 12X, Bufo 12X, Lachesis 12X, Lycopodium 12X, Sepia 12X, Silicea 12X, Thuja Occ 12X.

INDICATIONS & USAGE

USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

PURPOSE

USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

DOSAGE & ADMINISTRATION

DIRECTIONS:  Apply a small amount to affected area or as directed by a health care professional.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS

WARNINGS:

• FOR TOPICAL USE ONLY.
• Consult a physician for use in children under 12 years of age.
• IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
• KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
• Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Carbomer 940, Glycerin, Organic Aloe Vera, Purified Water, Sodium Hydroxmethylglycinate.

QUESTIONS

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES

**The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PRINCIPAL DISPLAY PANEL

NDC: 43406-0135-2

BLACK GEL

Warts*Skin Growths

TOPICAL HOMEOPATHIC GEL

 Net. Wt. 2oz. (56.7g)

INGREDIENTS AND APPEARANCE

BLACK 
echinacea ang., hydrastis, phytolacca, plantago, stellaria med., symphytum, trifolium prat., verbascum, arsenicum alb., bufo, lachesis, lycopodium, sepia, silicea, thuja occ. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43406-0135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	1 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	1 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	1 [hp_X]  in 1 g
PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR WHOLE	1 [hp_X]  in 1 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	1 [hp_X]  in 1 g
COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X)	COMFREY LEAF	1 [hp_X]  in 1 g
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	1 [hp_X]  in 1 g
VERBASCUM THAPSUS WHOLE (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS WHOLE	1 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 g
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q)	BUFO BUFO CUTANEOUS GLAND	12 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43406-0135-2	56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/20/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/20/2007

Labeler - Natural Creations, Inc (018022074)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc		030572478	manufacture(43406-0135)