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Odynia-U

Dosage form: patch
Ingredients: LIDOCAINE 4g in 100g, CAPSICUM .03g in 100g
Labeler: Ursh Pharmaceutical Inc.
NDC Code: 69647-003

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 Facts

Active Ingredient

Lidocaine 4 %

Capsicum 0.03 %


Purpose

Topical Analgesic

External Analgesic

Uses temporarily relieves minor aches and pains associated with:  -arthritis  -simple backache --bursitis  --tendonitis

--muscle strains --sprains  --bruises  --cramps

Warnings

For external use only

When using this product -use only as directed  -do not bandage tightly or use with a heating pad

-avoid contact with eyes and mucus membranes  -do not apply to wounds or damaged, broken or irritated skin

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

If pregnant or breast feeding, ask a health professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

adults and children over 12 years:

-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

-wear one Icy Hot Patch up to 8 hours

-repeat as necessary, but no more than 3 times daily

children under 12 years or younger:  ask a doctor

Inactive ingredients  aluminum hydroxide, carmellose sodium, glycerin, isopropyl myristate, methyl

acrylate / 2 -ethylhexyl acrylate copolymer, nonoxynol-30, polyacryic acid, polysorbate 80, sodium polyacrylate, sorbitan

sesquioleate, starch / acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

ODYNIA-U  
lidocaine, capsicum patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69647-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
CAPSICUM (CAPSICUM) CAPSICUM.03 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
2-ETHYLHEXYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
ACRYLIC ACID 
SODIUM 
SODIUM CHLORIDE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:69647-003-0115 PATCH in 1 BOX
110 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2015
Labeler - Ursh Pharmaceutical Inc. (079715344)

Revised: 05/2015
 
Ursh Pharmaceutical Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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