NDC Code(s) : 52810-214-11
Packager : PUREMEDY

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BABY ACNECALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS SALVE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52810-214
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
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
(SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) 		SAMBUCUS NIGRA FLOWER1 [hp_X] in 100 mL
THUJA OCCIDENTALIS LEAF(UNII: 0T0DQN8786)
(THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) 		THUJA OCCIDENTALIS LEAF1 [hp_X] in 100 mL
Inactive Ingredients
Ingredient Name Strength
OLIVE OIL(UNII: 6UYK2W1W1E)
YELLOW WAX(UNII: 2ZA36H0S2V)
COCOA BUTTER(UNII: 512OYT1CRR)
CANADA BALSAM(UNII: K304VI98I3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52810-214-1130 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(52810-214)

PRINCIPAL DISPLAY PANEL

BABY ACNE