Otc - Active Ingredient
Active ingredient Purpose
Lidocaine 4%................................................................Topical anesthetic
Dragon Pain Relief
FDA Label NDC 50066-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Dragon Pain Relief (NDC 50066-224). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
- temporarily relieves minor pain
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- more than 1 patch on your body at a time
- on cut, irritated or swollen skin
- at the same as other topical analgesics
- on puncture wounds
- for more than one week without consulting a doctor
Otc - When Using
When using this product
- use only as directed. Read and follow all directions and wanrings.
- do not allow contact with the eyes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- discontinue use at least 1 hour before a bath or shower
- dispose of used patch in manner that always keep product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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.
Indications & Usage
Directions
adults and children over 12 years:
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide
Dosage & Administration
Distributed by:
Genomma Lab USA, Inc.,
Houston, TX 77027
Made in China
* Please review the disclaimer below.
