Otc - Purpose
| Active ingredients | Purpose |
| Lidocaine HCL 4%............................ | Topical analgesic |
| Menthol 1%....................................... | Topical analgesic |
Lid O Creme Roll On
FDA Label NDC 63788-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Natural, Inc. for the product Lid O Creme Roll On (NDC 63788-111). 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 - purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breast feeding,, 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
Uses
For the temporary relief of pain.
Warnings
For external use only. Avoid contact with the eyes.
Do Not Use
in large quantities, particularly over raw surfaces, or blistered areas.
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breast Feeding,
ask a health professional before use.
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 affected area not more than 3 to 4 times daily
▪children under 2 years of age: consult a doctor
Other Information
▪ store in a cool dry place between (59-86°F)15-30°C
▪ don’t use if seal over cap is broken, torn, or missing
Inactive Ingredients
aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water
Questions Or Comments
+1-305-231-8977 (M-F) 9 A.M. - 5 P.M. EST or www.pharmanatural.com
Manufactured & Distributed By:
Pharma Natural, Inc.
Hialeah, FL 33016
Principal Display Panel
PAIN RELIEVING
Pharma Natural
Natural Health Solutions
Lid O Creme
Maximum Strength
Topical Analgesic Cream
Roll-On
LIDOCAINE HCL 4%
MENTHOL 1%
2.5 oz. (71 g)
* Please review the disclaimer below.
