NDC Code(s) : 76348-412-04
Packager : Renu Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CliXit (TM) acne eraserAcne Pen CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76348-412
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR0.28 g in 2.8 g
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SALICYLIC ACID(UNII: O414PZ4LPZ)
EDETIC ACID(UNII: 9G34HU7RV0)
CAMPHOR (NATURAL)(UNII: N20HL7Q941)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TROLAMINE(UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76348-412-041 in 1 BLISTER PACK 01/11/2016
12.8 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 10/25/2015

PRINCIPAL DISPLAY PANEL

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