Otc - Active Ingredient
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Nighttime 4x Medicated Cream (NDC 11822-6300). 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, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - stop use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
oral antiseptic
oral pain reliever
oral astringent
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this produt before. Stop use and seek immediate medical attention if you or a child in your care develops:
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.
Stop use and ask a doctor if
ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide
cut open tip of tube on score mark
adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor
children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.
children under 2 years of age: do not use
Do not use:
* Please review the disclaimer below.