Active Ingredients Purpose
Benzocaine 5.00%
Bite And Sting Relief
FDA Label NDC 36800-718
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care for the product Bite And Sting Relief (NDC 36800-718). 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 active ingredients purpose, uses, warningfor external use only, direction, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For temporarily relief of pain and itching associated with insect bites
Warningfor External Use Only
When using this product avoid contact with eyes and mucous membranes
Stop use and ask a doctor if condition worsens• symptoms last more than 7 days or clear up and occur again within a few days
Direction
Adults and children 2 years of age and older: • apply to the affected area nor mre than 3 to 4 times daily. Children under 2 years of age: consult a doctor
Inactive Ingredients
Water
PEG-2 Stearate
PEG-2 Stearate SE
SD Alcohol 40
Polyethylene
Hydrocortisone
Methylparaben
Aloe Barbadensis Leaf Extract
Propylparaben
Chamomilla Recutita (Matricaria) Flower Extract
Propylene Glycol
Diazolidinyl Urea
Disodium EDTA
Olea Europaea (Olive) Fruit Oil
Camphor
Menthol
Mentha Piperita (Peppermint) Oil
Eugenia Caryophyllus (Clove) Flower Oil
Papain
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