NDC Code(s) : 63742-007-00, 63742-007-01
Packager : Clinical Resolution Laboratory, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ARNICOOLMENTHOL CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63742-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
GLUCOSAMINE(UNII: N08U5BOQ1K)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
HELIANTHUS ANNUUS FLOWERING TOP(UNII: BKJ0J3D1BP)
EMU(UNII: 97P687I7AP)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
SHEA BUTTER(UNII: K49155WL9Y)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAVENDER OIL(UNII: ZBP1YXW0H8)
PEPPERMINT OIL(UNII: AV092KU4JH)
TEA TREE OIL(UNII: VIF565UC2G)
CAMPHOR OIL(UNII: 75IZZ8Y727)
TOCOPHEROL(UNII: R0ZB2556P8)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
EUCALYPTUS GUM(UNII: 72T9EZC2VX)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63742-007-0065 g in 1 JAR Type 0: Not a Combination Product15/05/2018
2NDC:63742-007-01130 g in 1 JAR Type 0: Not a Combination Product15/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 05/15/2018

LABELER - Clinical Resolution Laboratory, Inc.(825047942)

PRINCIPAL DISPLAY PANEL

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