NDC Code(s) : 75854-102-04, 75854-102-24
Packager : Avion Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ana-Lexhydrocortisone acetate and lidocaine hydrochloride CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE(UNII: 3X7931PO74)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE ACETATE20 mg in 1 g
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PLECTRANTHUS BARBATUS WHOLE(UNII: Q86533SAQ7)10 mg in 1 g
ALUMINUM SULFATE(UNII: 34S289N54E)
CALCIUM ACETATE(UNII: Y882YXF34X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
CETYL ALCOHOL(UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
TROLAMINE(UNII: 9O3K93S3TK)
UREA(UNII: 8W8T17847W)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-102-041 in 1 CARTON 28/02/2008
14 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
2NDC:75854-102-2424 in 1 CARTON 28/02/2008
24 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
unapproved drug other 02/28/2008

PRINCIPAL DISPLAY PANEL

RX ONLY      Net wt 4 g       NDC 75854-102-04

ANA-LEX™

Hydrocortisone Acetate 2% Lidocaine HCl 2%
in a 1% Coleus Forskohlii Base

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Directions Use only as directed by a physician. See package insert for
complete directions.

Store at Controlled Room Temperature 20°C to 25°C (68°F to 77°F)
excursions permitted between 15°C and 30°C (between 59°F and 86°F).

KEEP OUT OF THE REACH OF CHILDREN.

AVION
PHARMACEUTICALS

Manufactured for
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
Rev 0614

Tube - 4 grams