Otc - Active Ingredient
Active Ingredient
Lidocaine 4 %
Capsicum 0.03 %
Odynia-u
FDA Label NDC 69647-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ursh Pharmaceutical Inc. for the product Odynia-u (NDC 69647-003). 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, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
External Analgesic
Indications & Usage
Uses temporarily relieves minor aches and pains associated with: -arthritis -simple backache --bursitis --tendonitis
--muscle strains --sprains --bruises --cramps
Warnings
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
Otc - Stop Use
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
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 right away
Dosage & Administration
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 Ingredient
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
Package Label.Principal Display Panel
Copy Of Label (Lid Cap)
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