Label: SYNAGEL- diclofinac sodium gel
- NDC Code(s): 82213-002-01, 82213-002-02, 82213-002-03
- Packager: Noor Brands Company, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient.
- Uses
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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
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
SYNAGEL
diclofinac sodium gelProduct 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)
