NDC Code(s) : 45591-002-04
Packager : Pierson Laboratories, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chigg AwayBenzocaine LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45591-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
METHYLPARABEN(UNII: A2I8C7HI9T)
PETROLATUM(UNII: 4T6H12BN9U)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARIC ACID(UNII: 4ELV7Z65AP)
SULFUR(UNII: 70FD1KFU70)
TROLAMINE(UNII: 9O3K93S3TK)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)(UNII: L605B5892V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45591-002-04118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 12/01/2006

LABELER - Pierson Laboratories, Inc.(119184992)

REGISTRANT - Pharma Nobis, LLC(118564114)

Establishment
Name Address ID/FEI Business Operations
Pharma Nobis, LLC 118564114 analysis(45591-002), pack(45591-002), manufacture(45591-002), label(45591-002)

PRINCIPAL DISPLAY PANEL

NDC 45591-002-04
CHIGG
AWAY
RELIEVES ITCHING
REPELS CHIGGERS
4 FL OZ
(118 ML)

PRINCIPAL DISPLAY PANEL NDC 45591-002-04 CHIGG AWAY RELIEVES ITCHING REPELS CHIGGERS 4 FL OZ (118 ML)