NDC Code(s) : 52810-102-12
Packager : PUREMEDY

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE FREEECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, MAHONIA AQUIFOLIUM FRUITING TOP SALVE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52810-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECHINACEA ANGUSTIFOLIA(UNII: VB06AV5US8)
(ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) 		ECHINACEA ANGUSTIFOLIA1 [hp_X] in 100 mL
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
(CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) 		CALENDULA OFFICINALIS FLOWER1 [hp_X] in 100 mL
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
(SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) 		SAMBUCUS NIGRA FLOWER1 [hp_X] in 100 mL
MAHONIA AQUIFOLIUM FRUITING TOP(UNII: P119855ERN)
(MAHONIA AQUIFOLIUM FRUITING TOP - UNII:P119855ERN) 		MAHONIA AQUIFOLIUM FRUITING TOP1 [hp_X] in 100 mL
Inactive Ingredients
Ingredient Name Strength
OLIVE OIL(UNII: 6UYK2W1W1E)
SAFFLOWER OIL(UNII: 65UEH262IS)
YELLOW WAX(UNII: 2ZA36H0S2V)
PINE NEEDLE OIL (PINUS SYLVESTRIS)(UNII: 5EXL5H740Y)
CANADA BALSAM(UNII: K304VI98I3)
TEA TREE OIL(UNII: VIF565UC2G)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52810-102-1260 mL in 1 JAR Type 0: Not a Combination Product18/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/18/2012

LABELER - PUREMEDY(003552251)

Establishment
Name Address ID/FEI Business Operations
PUREMEDY 003552251 manufacture(52810-102)

PRINCIPAL DISPLAY PANEL

acne 1 oz label