Synagel
FDA Label NDC 82213-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Noor Brands Company, Llc for the product Synagel (NDC 82213-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient., purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- use only as directed
- do not bandage tightly
- avoid contact with eyes, nose or mouth
- 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.
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:
- 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
Image Description (Image 1 15ml)
Image Description (Image 2 15ml)
Image Description (Image 2 30ml)
Image Description (Image 2 100ml)
Image Description (Image 1 30ml)
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