Lidocaine and Prilocaine (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 30 Gram Tube Carton

NDC 42858-029-33

Lidocaine and
Prilocaine Cream, USP
2.5%/2.5%

Rx only

TO OPEN TUBE: Push cap down, turn, and lift off.
TO CLOSE TUBE: Push cap down and turn until it locks
into place.

Keep out of the reach of children.
(See opposite panel for additional information)

For Topical Use Only30 Grams

Rhodes

PRINCIPAL DISPLAY PANEL -- 30 Gram Tube Carton
(click image for full-size original)
LIDOCAINE AND PRILOCAINE lidocaine and prilocaine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42858-029
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine (Lidocaine) Lidocaine 25 mg in 1 g
Prilocaine (Prilocaine) Prilocaine 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PEG-54 HYDROGENATED CASTOR OIL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM HYDROXIDE
WATER
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42858-029-55 5 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (42858-029-55)
2 NDC:42858-029-33 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (42858-029-33)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213253 09/22/2021
Labeler — Rhodes Pharmaceuticals (831928986)
Establishment
Name Address ID/FEI Operations
Rafa Laboratories Ltd. 600024855 MANUFACTURE (42858-029)

Revised: 09/2020 Rhodes Pharmaceuticals

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