Otc - Active Ingredient
Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
Pain Relief Gel-roll On Gel
FDA Label NDC 84008-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bullet Point Llc for the product Pain Relief Gel-roll On (NDC 84008-002). 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, indications & usage, otc - ask doctor, warnings and precautions, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
(Lidocaine) Topical Anesthetic
(Menthol) Topical Analgesic
Warnings
Warnings
For external use only
Indications & Usage
Use
Temporary relief of pain
Do not use
• On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor.
When using this product
• Use only as directed. Read and follow all directions and warnings on this label
• Do not allow contact with eyes and mucous membranes
• Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use
• Do not use at the same time as other topical analgesics
Stop use if
• Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur within a few days
Otc - Ask Doctor
Ask a doctor if
• Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur within a few days
Warnings And Precautions
Flammable
• Keep away from fire or flame
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
- Ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact the Poison Control Center right away
Dosage & Administration
Directions
Adults and children 12 years of age and over:
- Apply a thin layer to the affected area for 6 to 8 hours
- Not to exceed 3 applications in a 24 hour period
Children under 12 years old: Consult a doctor
Inactive Ingredient
Inactive Ingredients
Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water
Other Safety Information
Child-resistant packaging. Close the cap tightly after use.
* Please review the disclaimer below.
