NDC Code(s) : 70994-403-07
Packager : Spry Life LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cool Mint Lip BalmCalendula officials flowers SALVE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-403
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 51.7 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
OLIVE OIL(UNII: 6UYK2W1W1E)
SUNFLOWER OIL(UNII: 3W1JG795YI)
JOJOBA OIL(UNII: 724GKU717M)
COCONUT OIL(UNII: Q9L0O73W7L)
MENTHA PIPERITA(UNII: 79M2M2UDA9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70994-403-074.25 g in 1 TUBE Type 0: Not a Combination Product19/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/01/2016

LABELER - Spry Life LLC(100791947)

PRINCIPAL DISPLAY PANEL

Green Goo Cool Mint Lip Balm