FDA Label for Pain Relief 4% Lidocaine
View Indications, Usage & Precautions
Pain Relief 4% Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Unexo Life Sciences Private Limited. 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.
Other
Drug Facts
Manufactured By:
UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)
Active Ingredient
Lidocaine 4.0%
Purpose
Topical anesthetic
Uses
Temporarily relieves minor pain.
Warnings
For external use only
Do Not Use
- More than one patch on your body at a time
- On cut, irritated or swollen skin
- On puncture wounds
- For more than one week without consulting a doctor
- If you are allergic to any active or inactive ingredients
- If pouch is damaged or opened.
When Using This Product
- Use only as directed
- Read and follow all directions and warnings on this pack
- Do not allow contact with the eyes
- Do not use at the same time as other topical analgesics
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use
- Do not microwave
- Dispose of used patch in manner that always keeps product away from children and pets
- Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use And Ask A Doctor If
- Condition worsens
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use
- Children 12 years of age or younger: Consult a physician.
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredients
aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water
Questions Or Comments
Call +91 9212228401
Principal Display Panel - One Patch Pouch
NDC: 71391-151-01
PAIN RELIEF
4% LIDOCAINE PATCH
Desensitizes aggravated nerves
and relieves pain
No-mess
Single-use application
Easy to apply and remove
Stay-put flexible gel patch
Unscented
1 PATCH
3.93 X 5.51 IN
(10cm X 14cm)
* Please review the disclaimer below.