DICLOFENAC SODIUM 3 PERCENT- diclofenac sodium cream
Humco Holding Group, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Diclofenac Sodium USP 3 Percent Cream

Harmful if swallowed. Causes serious eye irritation. Prevention: Wash thoroughly after handling. Do not eat, drink or smoke when using this product. Wear eye/face protection. Response: If swallowed: call a poison center/doctor/medical professional/ if you feel unwell. Rinse mouth. If in eyes. Rinse cautiously with water for several minutes. Remove contact lenses. If present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Disposal: Dispose of contents/container to an approved disposal site. Do Not Use if Sealing Pins are Broken or Removed. Store at: Controlled Room Temperature (20°C - 25°C).

Manufactured by:

Humco Holding Group

Texarkana, TX 75501

Made in USA

NDC 0395-6120-59

CAS # Diclofenac Sodium 15307-79-6

Diclofenac Sodium (USP) 3% Cream

FOR RX TOPICAL USE ONLY

Diclofenac Sodium, USP .................................................... 3.0%

Cream .................................................................................... 97.0%

2,500 grams

Not in Dosage Unit Form

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DICLOFENAC SODIUM 3 PERCENT
diclofenac sodium cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0395-6120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	300 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
OLEIC ACID (UNII: 2UMI9U37CP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHEAT GERM OIL (UNII: 14C97E680P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0395-6120-34	50 g in 1 JAR; Type 0: Not a Combination Product	06/01/2016
2	NDC:0395-6120-59	2500 g in 1 JAR; Type 0: Not a Combination Product	06/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/01/2016	11/01/2018

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Humco Holding Group, Inc (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc		825672884	label(0395-6120) , pack(0395-6120) , manufacture(0395-6120) , analysis(0395-6120)

Revised: 11/2018

Document Id: 799fced2-5765-da6e-e053-2a91aa0ae615

Set id: d4c64abb-8c51-4ea6-b13d-2cab05fb93ce

Version: 6

Effective Time: 20181101

Humco Holding Group, Inc