SYNAGEL- diclofinac sodium gel 
Noor Brands Company, LLC

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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Drug Facts

Active ingredient.

Diclofenac Sodium 1.0%

Purpose

Topical analgesic

Uses

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do Not Use

When using this product

Stop use and ask a doctor if

If pregnant of breastfeeding, ask a health professional before use.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children 12 years of age and older:

Children 12 years or younger: ask a doctor

Inactive ingredients

alcohol, chitosan, glycerin, lactic acid, water

Product label

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SYNAGEL 
diclofinac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82213-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
POLIGLUSAM (UNII: 82LKS4QV2Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82213-002-011 in 1 BLISTER PACK11/02/2023
114 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:82213-002-021 in 1 BOX11/02/2023
230 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:82213-002-031 in 1 BOX11/02/2023
3100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/02/2023
Labeler - Noor Brands Company, LLC (118242423)
Establishment
NameAddressID/FEIBusiness Operations
Noor Brands Company, LLC118242423manufacture(82213-002)

Revised: 11/2023
Document Id: 094013f2-0451-3ef7-e063-6394a90a2607
Set id: 2cd23e14-a1c9-497b-b734-8c99559b0f38
Version: 1
Effective Time: 20231103
 
Noor Brands Company, LLC