NDC Code(s) : 70994-504-04
Packager : Spry Life LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens First AidCalendula officials, Stellaria media, 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:70994-504
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 51.7 g
ST. JOHN'S WORT(UNII: UFH8805FKA)
(ST. JOHN'S WORT - UNII:UFH8805FKA) 		ST. JOHN'S WORT1 [hp_X] in 51.7 g
STELLARIA MEDIA(UNII: 2H03479QVR)
(STELLARIA MEDIA - UNII:2H03479QVR) 		STELLARIA MEDIA1 [hp_X] in 51.7 g
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
(CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) 		CALENDULA OFFICINALIS FLOWER1 [hp_X] in 51.7 g
PLANTAGO MAJOR(UNII: W2469WNO6U)
(PLANTAGO MAJOR - UNII:W2469WNO6U) 		PLANTAGO MAJOR1 [hp_X] in 51.7 g
COMMIPHORA MYRRHA WHOLE(UNII: UU81N77RI7)
(COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) 		COMMIPHORA MYRRHA WHOLE1 [hp_X] in 51.7 g
SALVIA OFFICINALIS WHOLE(UNII: M9C36LC10E)
(SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) 		SALVIA OFFICINALIS WHOLE1 [hp_X] in 51.7 g
COMFREY LEAF(UNII: DG4F8T839X)
(COMFREY LEAF - UNII:DG4F8T839X) 		COMFREY LEAF1 [hp_X] in 51.7 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
LARREA TRIDENTATA LEAF(UNII: PK0TXD049P)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
ROSEMARY OIL(UNII: 8LGU7VM393)
STYRAX BENZOIN RESIN(UNII: FE663Z8IRO)
LAVENDER OIL(UNII: ZBP1YXW0H8)
OLIVE OIL(UNII: 6UYK2W1W1E)
SUNFLOWER OIL(UNII: 3W1JG795YI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70994-504-0417 g in 1 TUBE Type 0: Not a Combination Product04/01/2016
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

Children