NDC Code(s) : 66096-169-03
Packager : OHM PHARMA INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OHM Acne ReliefCalendula Officinalis, Chamomilla, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Sulphur. GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66096-169
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP(UNII: 18E7415PXQ)
(CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) 		CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X] in 50 g
MATRICARIA CHAMOMILLA(UNII: G0R4UBI2ZZ)
(MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) 		MATRICARIA CHAMOMILLA1 [hp_X] in 50 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK(UNII: T7S323PKJS)
(HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) 		HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X] in 50 g
CALCIUM SULFIDE(UNII: 1MBW07J51Q)
(CALCIUM SULFIDE - UNII:1MBW07J51Q) 		CALCIUM SULFIDE6 [hp_X] in 50 g
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR6 [hp_X] in 50 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER 940(UNII: 4Q93RCW27E)
GLYCERIN(UNII: PDC6A3C0OX)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE(UNII: DIG6BWZ9XT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66096-169-0350 g in 1 TUBE Type 0: Not a Combination Product22/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/22/2016

PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-169-03

ACNE RELIEF GEL

Natural - Safe - Effective

No Side Effects

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