NDC Code(s) : 69842-849-02
Packager : CVS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cracked Heel Balm Dimethicone 1.00% STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69842-849
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL(UNII: Q9L0O73W7L)
SOYBEAN OIL(UNII: 241ATL177A)
YELLOW WAX(UNII: 2ZA36H0S2V)
CERESIN(UNII: Q1LS2UJO3A)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
SAFFLOWER OIL(UNII: 65UEH262IS)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SHEA BUTTER(UNII: K49155WL9Y)
SHOREA ROBUSTA SEED BUTTER(UNII: 39Z3Y92IX2)
ELAEIS GUINEENSIS FRUIT BUTTER(UNII: UYH3R74N56)
COCOA BUTTER(UNII: 512OYT1CRR)
MADHUCA LONGIFOLIA VAR. LATIFOLIA SEED BUTTER(UNII: 9Z5R7H666A)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
GARCINIA INDICA SEED BUTTER(UNII: US2H3D7800)
SHOREA STENOPTERA SEED BUTTER(UNII: 129R0X862G)
THEOBROMA GRANDIFLORUM SEED BUTTER(UNII: I711F13FXM)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
ASTROCARYUM ACULEATUM SEED OIL(UNII: JUP28JPX3K)
LEMON OIL(UNII: I9GRO824LL)
MANDARIN OIL(UNII: NJO720F72R)
ALMOND OIL(UNII: 66YXD4DKO9)
BLACK OLIVE(UNII: 2M6QWV94OC)
NIGELLA SATIVA SEED OIL(UNII: CS4U38E731)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CLOVE OIL(UNII: 578389D6D0)
AVOCADO OIL(UNII: 6VNO72PFC1)
SUNFLOWER OIL(UNII: 3W1JG795YI)
RICE BRAN OIL(UNII: LZO6K1506A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TOLNAFTATE(UNII: 06KB629TKV)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69842-849-0257 g in 1 BOTTLE, WITH APPLICATOR Type 0: Not a Combination Product12/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/12/2014

PRINCIPAL DISPLAY PANEL

image description