Otc - Active Ingredient
Active ingredient
Lidocaine 4%
Veiurkiu External Analgesic Cream
FDA Label NDC 85284-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product Veiurkiu External Analgesic Cream (NDC 85284-011). 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, inactive ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,
Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,
Mentha Arvensis Leaf, Chrysanthemum Indicum Top,
Portulaca, Polyoxyl 40 Hydrogenated Castor Oil
Otc - Purpose
Temporary relief of minor aches and pains
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains
Warnings
For external use only
Flammable: keep away from fire or flame
Otc - Stop Use
Stop use and ask a doctor if: condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Otc - Do Not Use
Do not use: on wounds or damaged skin with a heating pad
if allergic to menthol or any ingredient in this product
Otc - When Using
When using this product: avoid contact with eyes,
mucous membranes do not bandage tightly
Dosage & Administration
Directions
Adults and children 12 years and older: apply to affected area
not more than 3 to 4 times daily
Children under 12 years: ask a doctor
Other Safety Information
Store at 15–30°C (59–86°F)
Protect from excessive moisture and direct sunlight
Keep the carton for full labeling
Package Label.Principal Display Panel
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