NDC Code(s) : 61480-145-63
Packager : PLYMOUTH HEALTHCARE PRODUCTS LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNENiccolum Sulphuricum, Kali Bromatum, Zincum Oxydatum, Hepar Sulphuris Calcareum, Sulphur. TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61480-145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICKEL SULFATE HEXAHYDRATE(UNII: JC9WZ4FK68)
(NICKEL CATION - UNII:OIS2CXW7AM) 		NICKEL SULFATE HEXAHYDRATE3 [hp_X]
POTASSIUM BROMIDE(UNII: OSD78555ZM)
(BROMIDE ION - UNII:952902IX06) 		POTASSIUM BROMIDE1 [hp_X]
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION1 [hp_X]
CALCIUM SULFIDE(UNII: 1MBW07J51Q)
(CALCIUM SULFIDE - UNII:1MBW07J51Q) 		CALCIUM SULFIDE3 [hp_X]
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR1 [hp_X]
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
BLUEBERRY(UNII: 253RUG1X1A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (off-white with green speckles) Score 2 pieces
Shape ROUND Size 11 mm
Flavor BLUEBERRY Imprint Code LL
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61480-145-633 in 1 BOX 05/01/2016
120 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/01/2016

LABELER - PLYMOUTH HEALTHCARE PRODUCTS LLC(079330314)

PRINCIPAL DISPLAY PANEL

NDC# 61480-145-63

NATURAL active ingredients

LOMALUX

LABORATORIES

ACNE • PILL™

HEALTHY SKIN FROM WITHIN™

Relieves Acne Symptoms:

Adult/Teen

Back/Body

Hormonal

Rosacea

Promotes Skin Health

HOMEOPATHIC ORAL MEDICATION

DERMATOLOGIST DEVELOPED

Non - Irritating

Non - Drying

1 DAILY DOSE

Natural Berry Flavor

60PILLS

box labeling