Active Ingredient
Lidocaine 4%
Pain Relief Roll-on Liquid
FDA Label NDC 69452-393
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Pain Relief Roll-on (NDC 69452-393). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
For temporarily relief of pain and itching.
Warnings
For external use only.
When Using This Product
- use only as directed
- do not bandage tightly
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor
If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water
Carton Label
*compare to the active ingredient
in Aspercreme® Odor Free
with 4 % Lidocaine
NDC 69452-393-63
a+health™
maximum strength
pain relief
roll-on
lidocaine 4% HCl/
topical analgesic
odor free
no mess applicator
- temporarary relief of pain
- helps pain-affected areas
without irritation
2.5 fl oz (74mL)
with aloe
Carton (Carton)
* Please review the disclaimer below.
