SYNAGEL- diclofinac sodium gel

SynaGel by

Drug Labeling and Warnings

SynaGel by is a Otc medication manufactured, distributed, or labeled by Noor Brands Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient.

Diclofenac Sodium 1.0%

Purpose

Topical analgesic

Uses

• temporary relief from minor aches and pains associated with: 
• simple backache 
• arthritis 
• strains 
• bruises

Warnings

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

Do Not Use

• on wounds or damaged skin 
• with a heating pad or external heat

When using this product

• use only as directed 
• do not bandage tightly 
• avoid contact with eyes, nose or mouth

Stop use and ask a doctor if

• skin redness or irritation occurs 
• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

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.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and Children 12 years of age and older:

• Apply to affected area no more than 3 to 4 times daily 
• Allow to dry without rubbing

Children 12 years or younger: ask a doctor

Inactive ingredients

alcohol, chitosan, glycerin, lactic acid, water

Product label

INGREDIENTS AND APPEARANCE

SYNAGEL 
diclofinac sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82213-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLIGLUSAM (UNII: 82LKS4QV2Y)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82213-002-01	1 in 1 BLISTER PACK	11/02/2023
1		14 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82213-002-02	1 in 1 BOX	11/02/2023
2		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC: 82213-002-03	1 in 1 BOX	11/02/2023
3		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/02/2023

Labeler - Noor Brands Company, LLC (118242423)

Establishment
Name	Address	ID/FEI	Business Operations
Noor Brands Company, LLC		118242423	manufacture(82213-002)