NDC Code(s) : 70994-105-01, 70994-105-09
Packager : Spry Life LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cold Sore ReliefStellaria media, Salvia officinalis, Calendula officials, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACHILLEA MILLEFOLIUM FLOWER(UNII: YQR8R0SQEA)
(ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) 		ACHILLEA MILLEFOLIUM FLOWER1 [hp_X] in 19.8 g
ST. JOHN'S WORT(UNII: UFH8805FKA)
(ST. JOHN'S WORT - UNII:UFH8805FKA) 		ST. JOHN'S WORT1 [hp_X] in 19.8 g
STELLARIA MEDIA(UNII: 2H03479QVR)
(STELLARIA MEDIA - UNII:2H03479QVR) 		STELLARIA MEDIA1 [hp_X] in 19.8 g
SALVIA OFFICINALIS WHOLE(UNII: M9C36LC10E)
(SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) 		SALVIA OFFICINALIS WHOLE1 [hp_X] in 19.8 g
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
(CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) 		CALENDULA OFFICINALIS FLOWER1 [hp_X] in 19.8 g
PLANTAGO MAJOR(UNII: W2469WNO6U)
(PLANTAGO MAJOR - UNII:W2469WNO6U) 		PLANTAGO MAJOR1 [hp_X] in 19.8 g
COMMIPHORA MYRRHA WHOLE(UNII: UU81N77RI7)
(COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) 		COMMIPHORA MYRRHA WHOLE1 [hp_X] in 19.8 g
COMFREY LEAF(UNII: DG4F8T839X)
(COMFREY LEAF - UNII:DG4F8T839X) 		COMFREY LEAF1 [hp_X] in 19.8 g
Inactive Ingredients
Ingredient Name Strength
MELISSA OFFICINALIS(UNII: YF70189L0N)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
STYRAX BENZOIN RESIN(UNII: FE663Z8IRO)
LAVENDER OIL(UNII: ZBP1YXW0H8)
OLIVE OIL(UNII: 6UYK2W1W1E)
YELLOW WAX(UNII: 2ZA36H0S2V)
LARREA TRIDENTATA LEAF(UNII: PK0TXD049P)
ROSEMARY OIL(UNII: 8LGU7VM393)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70994-105-091 in 1 BOX 04/02/2019
1NDC:70994-105-0119.8 g in 1 CAN Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/02/2019

LABELER - Spry Life LLC(100791947)

PRINCIPAL DISPLAY PANEL

Cold Sore Relief