NDC Code(s) : 10237-738-18, 10237-738-19
Packager : Church & Dwight Co., Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Orajel Nighttime Instant Relief for Teething Pain Benzocaine GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10237-738
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
GELATIN (UNII: 2G86QN327L)
MINERAL OIL(UNII: T5L8T28FGP)
PECTIN(UNII: 89NA02M4RX)
PETROLATUM(UNII: 4T6H12BN9U)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
FD&C RED NO. 40(UNII: WZB9127XOA)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10237-738-191 in 1 CARTON
1NDC:10237-738-181 in 1 CARTON
15.1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/18/2010

PRINCIPAL DISPLAY PANEL

No. 1 TEETHING BRAND
        used by Pediatricians

                          Nighttime
                      Orajel
        

Instant Relief for Teething Pain                            cherry flavored gel

LONGER LASTING           EXTRA STRENGTH   for Nighttime

NET WT 0.18 OZ (5.1g) GEL            ORAL PAIN RELIEVER FOR TEETHING       BENZOCAINE 10%

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