NDC Code(s) : 71304-001-00
Packager : Canadian Unique Health Ltd.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CU Pain Away Pain ReliefMENTHOL CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71304-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL12.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE(UNII: V5VD430YW9)
AVOCADO OIL(UNII: 6VNO72PFC1)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
COCO-CAPRYLATE(UNII: 4828G836N6)
COCONUT OIL(UNII: Q9L0O73W7L)
CUPRIC OXIDE(UNII: V1XJQ704R4)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ISOAMYL COCOATE(UNII: 14OG46E98E)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
JOJOBA OIL(UNII: 724GKU717M)
LAVENDER OIL(UNII: ZBP1YXW0H8)
LEMON OIL(UNII: I9GRO824LL)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYSORBATE 60(UNII: CAL22UVI4M)
AMINO ACIDS, SILK(UNII: V0L00EX1IA)
SODIUM LACTATE(UNII: TU7HW0W0QT)
STEARIC ACID(UNII: 4ELV7Z65AP)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71304-001-001 in 1 BOX 03/08/2017
150 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 03/08/2017

LABELER - Canadian Unique Health Ltd.(203413273)

PRINCIPAL DISPLAY PANEL

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