Label: DRAGON PAIN RELIEF- lidocaine patch
- NDC Code(s): 50066-224-05
- Packager: Genomma Lab USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 31, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
-
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.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DRAGON PAIN RELIEF
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg Inactive Ingredients Ingredient Name Strength SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-224-05 5 in 1 CARTON 01/18/2019 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/18/2019 Labeler - Genomma Lab USA, Inc. (832323534)