Otc - Active Ingredient
Active ingredient :
1% Menthol .…
Purpose
Topical Analgesic
Olelon Numbing Cream
FDA Label NDC 85593-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Olelon Numbing (NDC 85593-018). 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, warnings, otc - keep out of reach of children, inactive ingredient, indications & usage, dosage & administration, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
UseFor the temporary relief of localized pain, itching ordiscomfort from minor skin irritations.
Warnings
Warnings For external use only. Avoid contact with the eyes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIn case of accidental ingestion, seek medical helpimmediately.
Inactive Ingredient
Water, Propylene glycol, Carbomer Homopolymer, Glycerin,Edetate Disodium,Hydroxyacetophenone, 1,2-Hexanediol,Chrysanthellum Indicum Top, Purslane, Polyoxyl 40hydrogenated castor oil
Indications & Usage
Directions Adults: Clean the affected area with mild soap and warmwater and rinse thoroughly, Gently dry by patting with toilettissue or a soft cloth before application of this product.Children under 12 years of age: consult a doctor.
Dosage & Administration
1.Clean hands and treatment area with mild soap andwarm water, rinse thoroughly, then gently pat dry.2.Apply a thick layer of numbing cream to the treatmentarea, making sure to cover both the treatment area andits surroundings.3.Wrap tightly with plastic wrap and wait 40 -60 minutes(Longer time, better effect.)4.Wipe away residue, and wait another 15 -25 minutes forthe numbness to peak.
5.Begin the procedure.
Otc - When Using
When using this product Do not exceed the recommendeddaily dosage unless directed by a doctor. Certain personscan develop allergic reactions to the ingredients in this product.Do not put this product into the rectum by using finger.
Package Label.Principal Display Panel
Labeling (85593 018 01)
* Please review the disclaimer below.
