NDC Code(s) : 52810-219-24
Packager : PUREMEDY

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALL NATURAL WOUND AND BURNCALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52810-219
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
(CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) 		CALENDULA OFFICINALIS FLOWER1 [hp_X] in 100 mL
ECHINACEA ANGUSTIFOLIA(UNII: VB06AV5US8)
(ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) 		ECHINACEA ANGUSTIFOLIA1 [hp_X] in 100 mL
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
(SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) 		SAMBUCUS NIGRA FLOWER1 [hp_X] in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE(UNII: V5VD430YW9)
OLIVE OIL(UNII: 6UYK2W1W1E)
MARITIME PINE(UNII: 50JZ5Z98QY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52810-219-24118 mL in 1 BOTTLE Type 0: Not a Combination Product09/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/09/2016

LABELER - PUREMEDY(003552251)

Establishment
Name Address ID/FEI Business Operations
PUREMEDY 003552251 manufacture(52810-219)

PRINCIPAL DISPLAY PANEL

Wound Burn Spray Label - 4 oz