Otc - Active Ingredient
Active ingredient Purpose
Menthol, 0.11%...........Topical analgesic, antipruritic
Benova Pain And Itch Relief Lotion
FDA Label NDC 87150-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benova Rx Llc for the product Benova Pain And Itch Relief (NDC 87150-001). 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, otc - when using, dosage & administration, storage and handling, inactive ingredient, warnings, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For temporary relief of pain & itching associated with insect bites, sunburn, minor cuts, scrapes, minor skin irritations, and fever blisters & cold sores.
Otc - When Using
Warnings
For external use only.
Avoid contact with eyes.
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, discontinue use of this product & consult a doctor.
Dosage & Administration
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult
a doctor.
Storage And Handling
Other information
Protect this product from excessive heat and sun.
Do not use if seal is broken.
Inactive Ingredient
Inactive ingredients
Water, Cyclopentasiloxane, Dimethicone, Dimethi- cone/PEG-10/15 Crosspolymer, Potassium Sorbate, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Actinidia Deliciosa, Brazilian Peppertree Extract (Schinus terebinthifolius), Red Root Extract (Ceanothus americanus), Licorice Root Extract, Bromelain, Nisin, Sodium Bicarbonate, Disodium EDTA, Sodium Hydroxide, Citric Acid.
Warnings
Warnings
For external use only.
Avoid contact with eyes.
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, discontinue use of this product & consult a doctor.
Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Package Label.Principal Display Panel
Benova®
Pain & Itch
Relief Lotion
+Immediate Relief
+Steroid-Free Relief
+Gentle On Sensitive Skin
3 FL OZ (90 mL)
See uploaded image Benova_PainItchReliefLotion_3floz_PeelBack_FullLabel.jpg.
Benova_painitchrelieflotion_3floz_peelback_fulllabel (Benova Painitchrelieflotion 3floz Peelback Fulllabel)
* Please review the disclaimer below.
