Active Ingredient
Lidocaine HCl 5%
Welahead By Welmate Lidocaine 5% Roll-on Solution
FDA Label NDC 83833-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Otc Pharm Llc for the product Welahead By Welmate Lidocaine 5% Roll-on (NDC 83833-101). 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 active ingredient, purporse, use, warnings, otc - keep out of reach of children, directions, inactive ingrediants, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purporse
Topical Analgesic
Use
Temporarily Relieves minor pain
Warnings
For external use only
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than week without consulting a doctor
- use cnly as directed. Read and follow all directions and warnings on this carton
- do not allow contact with the eyes and mucous membranes
- do not bandage or apply a local heat (such as heating pads) to the area of use
- condition worsens
- skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
- symptoms persist for more than 7 days or clear up and occur again within a days
- keep away from fire or flame
When using this product:
Stop use and aska doctor if
Flammable
If pregnant or breast freding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children over 12 years:
apply a thin layer to affeced area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
Children 12 years and younger: ask a doctor
Inactive Ingrediants
purified water, ethyl alcohol, propylene glycol, polysorbate 20, triethanolamine, phenoxyethanol, ethylhexylglycerin,
potassium carbomer, aloe vera, glycerin, chonüoitin sulfate, glucosamine sulfate, methylsulfonylmethane
* Please review the disclaimer below.
