Label: ACNE- kali bromatum, natrum bromatum, niccolum sulphuricum, sulphur, hepar suphuris calcareum, tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 57520-0710-1, 57520-0710-2, 57520-0710-3 - Packager: Apotheca Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated July 15, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
WARNINGS: If symptoms persist or worsen, contact a physician.
If pregnant or nursing, use only under the advice and supervision of a physician.
Keep out of the reach of children.
CAUTION: Use only as directed.
Do not give to children under six years old or use in the presence of kidney disease.
If skin rash appears, or if nervous symptoms persist, recur frequently or are unusual, discontinue use and consult a physician.
SAFETY SEALED for your protection. Do not use if imprinted seal around bottle neck and cap is missing or broken.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE
kali bromatum, natrum bromatum, niccolum sulphuricum, sulphur, hepar suphuris calcareum, tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0710 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BROMIDE (UNII: OSD78555ZM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE 1 [hp_X] SODIUM BROMIDE (UNII: LC1V549NOM) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BROMIDE 2 [hp_X] NICKEL SULFATE HEXAHYDRATE (UNII: JC9WZ4FK68) (NICKEL - UNII:7OV03QG267) NICKEL SULFATE HEXAHYDRATE 6 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE 9 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (off white) Score no score Shape ROUND (cylindrical) Size 9mm Flavor Imprint Code LL; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57520-0710-3 1 in 1 CARTON 1 NDC:57520-0710-2 1 in 1 CARTON 1 NDC:57520-0710-1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/15/2011 Labeler - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture
