Ziclopro (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — Kit Carton Label

Rx Only
NDC 73516-801-01

Ziclopro™

Diclofenac Sodium Topical Solution
(1.5% w/w, 5 fl oz/150mL)

Capsaicin Cream
(Capsaicin 0.025%, 8 fl oz/237mL)

ASHOKA™ Health

PRINCIPAL DISPLAY PANEL -- Kit Carton Label
(click image for full-size original)
ZICLOPRO diclofenac sodium and capsaicin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73516-801
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73516-801-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 150 mL
Part 2 1 BOTTLE, PUMP 237 mL
Part 1 of 2
DICLOFENAC SODIUM diclofenac sodium solution/ drops
Product Information
Item Code (Source) NDC:51021-250
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Sodium (Diclofenac) Diclofenac Sodium 16.05 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51021-250-05 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204132 08/20/2015
Part 2 of 2
BIO-SORB capsaicin cream
Product Information
Item Code (Source) NDC:51021-302
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capsaicin (Capsaicin) Capsaicin 0.025 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
TROLAMINE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
ALOE VERA LEAF
GREEN TEA LEAF
LEVOMENOL
POLYETHYLENE GLYCOL 800
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POLYGLYCERYL-3 OLEATE
CAPRYLYL GLYCOL
METHYLISOTHIAZOLINONE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51021-302-08 237 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/20/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204132 06/10/2020
Labeler — Ashoka Health (117297878)

Revised: 06/2021 Ashoka Health

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