FDA Label for Pain Relief Gel-roll On
View Indications, Usage & Precautions
Pain Relief Gel-roll On Product Label
The following document was submitted to the FDA by the labeler of this product Bullet Point Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
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.
