FDA Label for Sync Quadra
View Indications, Usage & Precautions
Sync Quadra Product Label
The following document was submitted to the FDA by the labeler of this product Ion Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Drug facts
Active ingredients (in each patch)...... Purpose
Menthol 10% ............................................. Topical analgesic
Methyl salicylate 15% .............................. Topical analgesic
Capsaicin 0.025% ................................. Topical analgesic
Methyl nicotinate 1% ............................. Topical analgesic
Uses Section
Uses:
Temporarily relieves minor aches and pains of muscles & joints associated with:
- Strains
- Sprains
- Simple Backache
- Arhtritis
- Bruises
Nsaid Warning, Do Not Use Section
For external use only
Stomach bleeding warning: This product contains a NSAID, which may cause stomach bleeding. The chance is small but higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- on the face or rashes
- on wounds or damaged skin
- if allergic to aspirin or other NSIADs
- with a heating pad
- when sweating (such as from exercise or heat)
- any patch from a pouch that has been open 14 days or more days
- right before or after heart surgery
- do not bandage tightly
Do not use:
When Using This Product
When using this product
wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop Use Section
Stop use and ask a doctor if
- condition worsens
- symptoms last for more than 7 days or clear up and occur again within a few days
- you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or have bloody or black stools
- redness or swelling occurs
- a burning sensation occurs
If Pregnant Or Breast-Feeding Section
Ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children Section
If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.
Directions Section
Adults and children 10 years of age and older:
only use one patch at a time
clean and dry affected area
remove patch from backing film and apply to skin (see illustration)
apply 1 patch to the affected area or intact skin up to 36 hours
do not use more than 2 patches per day
do not use for more than 3 days in a row unless prescribed and instructed by a healthcare provider
the used patch should be removed from the skin when a new one is applied
Inactive Ingredient
Hypoallergenic acrylic adhesive
Questions Or Comments Section
Questions or Comments:
833.711.8833
Package Label.Principal Display Panel
* Please review the disclaimer below.